Hospira Inc.
Medical device manufacturer in Lake Forest, IL.
45510(k) clearances
1PMA approvals
274recalls
Device types
- FPA Set, Administration, Intravascular 14
- FRN Pump, Infusion 12
- DQE Catheter, Oximeter, Fiber-Optic 5
- MEA Pump, Infusion, Pca 3
- DRS Transducer, Blood-Pressure, Extravascular 2
- KNT Tubes, Gastrointestinal (And Accessories) 1
- IQG Adaptor, Holder, Syringe 1
- FPK Tubing, Fluid Delivery 1
- QBP Cap, Device Disinfectant 1
- DRG Transmitters And Receivers, Physiological… 1
- NGT Saline, Vascular Access Flush 1
- KPE Container, I.V. 1
- LHI Set, I.V. Fluid Transfer 1
- MRZ Accessories, Pump, Infusion 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleFRN · Traditional | 03/28/2017SE |
| K161036 | Hospira Extension Set, Hospira Primary SetFPA · Traditional | 01/06/2017SE |
| K160492 | Hospira Sapphire SetsMRZ · Traditional | 12/06/2016SE |
| K160870 | Hospira Administration SetsFPA · Special | 06/01/2016SE |
| K143612 | LifeCare PCA Infusion SystemMEA · Traditional | 04/08/2016SE |
| K143087 | Hospira Blood SetFPA · Traditional | 03/04/2015SE |
| K143015 | Hospira Primary SetsFPA · Traditional | 02/25/2015SE |
| K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play Ce 3.0 Module for…FRN · Traditional | 01/16/2015SE |
| K142622 | IV AdministrationFPA · Traditional | 01/15/2015SE |
| K142974 | Extension SetsFPA · Traditional | 01/09/2015SE |
| K142433 | Hospira Extension SetFPA · Traditional | 12/08/2014SE |
| K142367 | Hospira Primary SetsFPA · Traditional | 11/25/2014SE |
| K141102 | Hospira Mednet Medication Management SuiteFRN · Special | 07/08/2014SE |
| K133602 | Add-Vantage AddaptorLHI · Traditional | 01/24/2014SE |
| K132276 | Sterile Empty Glass Container, 250ML, Sterile Empty Glass Container, 500 ML, Sterile…KPE · Traditional | 11/12/2013SE |
| K121032 | Primary Symbiq Set, Dital Microbore Tubing, 0.2 Micron Filter, Non-DehpFPA · Special | 06/21/2012SE |
| K110901 | Symbiq Infusion and Adminstration SetFRN · Traditional | 03/05/2012SE |
| K113683 | Lifeshield Vision Infusion Set with Pre-Pierced ResealFPA · Special | 01/12/2012SE |
| K103224 | Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingFPA · Special | 01/07/2011SE |
| K103344 | Infusion SetsFPA · Special | 12/10/2010SE |
| K101677 | Hospira Infusion Blood SetsFPA · Special | 08/11/2010SE |
| K090882 | Flush Syringe Filled with 0.9% Sodium ChlorideNGT · Traditional | 04/23/2010SE |
| K091268 | Hospira Latex-Free Critical Care and Advanced Sensor CathetersDQE · Special | 09/18/2009SE |
| K090610 | Hospira Vital Signs Wireless Monitoring SystemDRG · Traditional | 03/13/2009SE |
| K081412 | Plum A+ Hyperbaric Infusion System with Hospira Mednet SoftwareFRN · Traditional | 12/17/2008SE |
| K083019 | Gemstar SP Infusion System with Gemstar SP Infusion Suite SoftwareFRN · Traditional | 10/22/2008SE |
| K080579 | Effectiv (TM) CapQBP · Traditional | 09/11/2008SE |
| K070398 | Hospira Plum A+ Infusion Pump, Model 12391FRN · Special | 04/24/2007SE |
| K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 &…FPK · Traditional | 12/11/2006SE |
| K063180 | Isecure Syringe Cartridge HolderIQG · Special | 12/11/2006SE |
| K062999 | Opticath Central Venous Oximetry Probe with Seal with HeparinDQE · Special | 11/03/2006SE |
| K061585 | Opticath Central Venous Oximetry CatheterDQE · Traditional | 10/05/2006SE |
| K061573 | Transpac III Disposable Straight Pressure Transducer and KitDRS · Special | 09/19/2006SE |
| K061432 | Hospira Enteral Feeding Set, Model 20640KNT · Traditional | 09/11/2006SE |
| K061450 | Hospira Latex-Free Advanced Sensor Catheters; Hospira Latex-Free Critical Care CathetersDQE · Traditional | 08/04/2006SE |
| K061159 | Opticath Central Venous Oximetry Probe with Fluidic Seal With/Without HeparinDQE · Traditional | 06/26/2006SE |
| K060806 | Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086…FRN · Special | 04/21/2006SE |
| K052828 | Disposable Transpac III Integrated Transducer (It)DRS · Special | 02/17/2006SE |
| K052722 | Lifeshield Latex-Free Microbore Extension Set, Model 14949 and OthersFPA · Special | 11/02/2005SESU |
| K052052 | Hospira Plum A+ Infusion Pump System V11.5, Hospira Plum A+ 3 Infusion Pump System, V11.5FRN · Special | 08/24/2005SE |
| K043256 | Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System…MEA · Special | 12/06/2004SE |
| K042980 | Hospira Gemstar Infusion Pump System, Hospira Gemstar Connect SoftwareFRN · Special | 11/17/2004SE |
| K042800 | Lifecare Pca Infusion System with Hospira Mednet SoftwareMEA · Traditional | 10/18/2004SE |
| K042609 | Hospira Mednet Medication Management SuiteFRN · Traditional | 10/06/2004SE |
| K042081 | Plum A+ Infusion System with Hospira Mednet Software , and Plum A+3 Infusion System with…FRN · Traditional | 08/24/2004SE |
PMA approvals
- P880028 Dextran HM 32% · 05/30/1989 · 6 supplements
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-1833-2016 Class II | The Plum A+ is a dual-line volumetric infusion system designed to meet the growing…Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to… | 03/25/2016Terminated |
| Z-1832-2016 Class II | The Plum 360 is a large volume infuser capable of delivering fluids for a variety of…Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to… | 03/25/2016Terminated |
| Z-0863-2016 Class II | The Symbiq infusion pump is a device used in a health care facility to pump fluids into…Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad. | 12/22/2015Terminated |
| Z-1075-2015 Class I | The Plum A+ Infusion System is designed to meet the fluid delivery requirements of…One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume… | 07/02/2014Terminated |
| Z-1074-2015 Class I | The Plum A+ Infusion System is designed to meet the fluid delivery requirements of…One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume… | 07/02/2014Terminated |
| Z-1073-2015 Class I | The Plum A+ Infusion System is designed to meet the fluid delivery requirements of…One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume… | 07/02/2014Terminated |
| Z-1072-2015 Class I | The Plum A+ Infusion System is designed to meet the fluid delivery requirements of…One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume… | 07/02/2014Terminated |
| Z-1071-2015 Class I | The Plum A+ Infusion System is designed to meet the fluid delivery requirements of…One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume… | 07/02/2014Terminated |
| Z-1050-2015 Class II | Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part…Plum A+ infusion system pole clamp assemblies were discovered to be cracked. If the knob on the pole clamp… | 06/11/2014Terminated |
| Z-2027-2014 Class II | The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet…Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg/min" and… | 06/06/2014Terminated |
| Z-1627-2014 Class II | LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection…The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the… | 03/25/2014Terminated |
| Z-1626-2014 Class II | LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible…The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the… | 03/25/2014Terminated |
| Z-1625-2014 Class II | LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or…The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the… | 03/25/2014Terminated |
| Z-1624-2014 Class II | LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch…The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the… | 03/25/2014Terminated |
| Z-1623-2014 Class II | LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with…The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the… | 03/25/2014Terminated |
| Z-1479-2014 Class II | LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with…Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the… | 02/25/2014Terminated |
| Z-1512-2014 Class I | GemStar Docking Station, used with GemStar infusion pump, in combination with other…There are two situations that may occur when using the GemStar Docking Station, List Number 13075-XX-XX, in… | 02/18/2014Terminated |
| Z-0096-2015 Class I | The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two…The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance… | 02/03/2014Terminated |
| Z-0095-2015 Class I | The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two…The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance… | 02/03/2014Terminated |
| Z-2031-2014 Class II | GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain…The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify… | 01/31/2014Terminated |
| Z-1704-2014 Class II | Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System…There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of… | 01/24/2014Terminated |
| Z-1703-2014 Class II | Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port…There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of… | 01/24/2014Terminated |
| Z-1702-2014 Class II | LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of…There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of… | 01/24/2014Terminated |
| Z-1483-2014 Class I | Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including…Broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it… | 10/31/2013Terminated |
| Z-1482-2014 Class I | Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole…Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore… | 10/31/2013Terminated |
| Z-1126-2014 Class II | *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA…Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled… | 10/25/2013Terminated |
| Z-2594-2016 Class II | Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01…Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal… | 09/10/2013Terminated |
| Z-2593-2016 Class II | Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, ATS, 2000…Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal… | 09/10/2013Terminated |
| Z-2062-2016 Class II | *** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON…Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. | 09/09/2013Terminated |
| Z-2061-2016 Class II | *** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET…Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. | 09/09/2013Terminated |
| Z-2060-2016 Class II | *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron…Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. | 09/09/2013Terminated |
| Z-2059-2016 Class II | *** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING…Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. | 09/09/2013Terminated |
| Z-2058-2016 Class II | *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET…Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. | 09/09/2013Terminated |
| Z-0372-2014 Class II | *** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; *** E09 batteries…Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the correct E09… | 08/28/2013Terminated |
| Z-0457-2014 Class II | Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE…Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be… | 07/17/2013Terminated |
| Z-1751-2013 Class II | LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN…Hospira has received reports of customers experiencing air-in-line alarms related to administration sets… | 06/18/2013Terminated |
| Z-1858-2013 Class I | List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site…It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture… | 04/01/2013Terminated |
| Z-1857-2013 Class I | List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, Non-Vented…It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture… | 04/01/2013Terminated |
| Z-1856-2013 Class I | List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110…It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture… | 04/01/2013Terminated |
| Z-1855-2013 Class I | List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 Inch…It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture… | 04/01/2013Terminated |
| Z-1854-2013 Class I | List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170…It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture… | 04/01/2013Terminated |
| Z-1853-2013 Class I | List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Blood Product…It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture… | 04/01/2013Terminated |
| Z-1852-2013 Class I | List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin…It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture… | 04/01/2013Terminated |
| Z-1851-2013 Class I | List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood Product…It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture… | 04/01/2013Terminated |
| Z-1850-2013 Class I | List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood…It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture… | 04/01/2013Terminated |
| Z-1117-2013 Class II | The GemStar Pump is a small and lightweight, single channel infusion device designed for…During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication… | 03/21/2013Terminated |
| Z-1116-2013 Class II | The GemStar Pump is a small and lightweight, single channel infusion device designed for…During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication… | 03/21/2013Terminated |
| Z-0422-2015 Class II | GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain…Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar… | 03/19/2013Terminated |
| Z-0421-2015 Class II | GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain…Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar… | 03/19/2013Terminated |
| Z-1170-2013 Class I | The GemStar Pump is a small and lightweight, single channel infusion device designed for…Pump shutting off during use without warning. | 03/18/2013Terminated |
| Z-1169-2013 Class I | The GemStar Pump is a small and lightweight, single channel infusion device designed for…Pump shutting off during use without warning. | 03/18/2013Terminated |
| Z-1160-2013 Class I | GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight…Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's… | 03/18/2013Terminated |
| Z-1159-2013 Class I | GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight…Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's… | 03/18/2013Terminated |
| Z-0350-2014 Class I | The GemStar Pump is a small and lightweight, single channel infusion device designed for…The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or… | 03/15/2013Terminated |
| Z-0349-2014 Class I | The GemStar Pump is a small and lightweight, single channel infusion device designed for…The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or… | 03/15/2013Terminated |
| Z-2874-2016 Class II | LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or…Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the… | 03/08/2013Terminated |
| Z-2873-2016 Class II | LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709…Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the… | 03/08/2013Terminated |
| Z-2142-2016 Class II | The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of…Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a… | 03/08/2013Terminated |
| Z-2141-2016 Class II | LifeCare PCA infusion system with Hospira MedNet software allows clinicians to…Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a… | 03/08/2013Terminated |
| Z-2140-2016 Class II | The PCA 3 system cam be used in a wide range of clinical settings, including but not…Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a… | 03/08/2013Terminated |
| Z-2139-2016 Class II | The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic…Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a… | 03/08/2013Terminated |
| Z-1518-2015 Class II | The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or…The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in… | 02/27/2013Terminated |
| Z-1517-2015 Class II | The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia…The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in… | 02/27/2013Terminated |
| Z-1016-2017 Class II | Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended…Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin… | 02/19/2013Terminated |
| Z-2730-2016 Class II | Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2729-2016 Class II | Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2728-2016 Class II | Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2727-2016 Class II | Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2726-2016 Class II | Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2725-2016 Class II | Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2724-2016 Class II | Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2723-2016 Class II | Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-2722-2016 Class II | Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a…The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and… | 02/06/2013Terminated |
| Z-0354-2017 Class II | Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V.…Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This… | 02/05/2013Terminated |
| Z-0353-2017 Class II | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V.…Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This… | 02/05/2013Terminated |
| Z-2056-2016 Class II | Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V.…Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027.… | 02/04/2013Terminated |
| Z-2055-2016 Class II | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V.…Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027.… | 02/04/2013Terminated |
| Z-1847-2013 Class II | The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions…The devices secondary audio signal fails to activate. | 02/04/2013Terminated |
| Z-0306-2017 Class II | Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V.…Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO)… | 02/04/2013Terminated |
| Z-0305-2017 Class II | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V.…Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO)… | 02/04/2013Terminated |
| Z-0290-2014 Class II | The Plum A+ Infusion System is a cassette based multifunction infusion system that…Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal… | 02/01/2013Terminated |
| Z-0289-2014 Class II | The Plum A+3 Infusion System is a cassette based multifunction infusion system that…Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal… | 02/01/2013Terminated |
| Z-0288-2014 Class II | The Plum A+3 Infusion System is a cassette based multifunction infusion system that…Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal… | 02/01/2013Terminated |
| Z-0287-2014 Class II | The Plum A+ Infusion System is a cassette based multifunction infusion system that…Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal… | 02/01/2013Terminated |
| Z-0286-2014 Class II | The Plum A+3 Infusion System is a cassette based multifunction infusion system that…Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal… | 02/01/2013Terminated |
| Z-0285-2014 Class II | The Plum A+ Infusion System is a cassette based multifunction infusion system that…Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal… | 02/01/2013Terminated |
| Z-0284-2014 Class II | The Plum A+ Infusion System is a cassette based multifunction infusion system that…Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal… | 02/01/2013Terminated |
| Z-0283-2014 Class II | The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system…Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal… | 02/01/2013Terminated |
| Z-0626-2013 Class II | Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045…The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can… | 12/07/2012Terminated |
| Z-0625-2013 Class II | Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps…The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can… | 12/07/2012Terminated |
| Z-0624-2013 Class II | Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps…The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can… | 12/07/2012Terminated |
| Z-0483-2013 Class II | Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity…The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not… | 10/26/2012Terminated |
| Z-0482-2013 Class II | Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a…The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not… | 10/26/2012Terminated |
| Z-0481-2013 Class II | Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired…The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not… | 10/26/2012Terminated |
| Z-0070-2013 Class I | Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V.…The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may… | 08/29/2012Terminated |
| Z-0069-2013 Class I | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V.…The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may… | 08/29/2012Terminated |
| Z-2395-2012 Class II | Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for…Embedded iron oxide glass defect which may have the potential to break off into the solution. | 08/28/2012Terminated |
| Z-2346-2012 Class II | Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira…Reports of leaking during filling and administration. | 08/02/2012Terminated |
| Z-2075-2012 Class II | Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2…The float valve in the burette sticks to the burette wall and does not open or close properly. | 07/13/2012Terminated |
| Z-1491-2012 | LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per…The Lifeshield Primary Plumsets may cause a cassette test failure alarm when the set is loaded onto the… | 04/25/2012Terminated |
| Z-1463-2012 | GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and…Hospira has received customer reports of bolus delivery failures when using the GemStar bolus cord. Possible… | 03/28/2012Terminated |
| Z-0209-2014 Class II | *** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use…Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following… | 02/05/2012Terminated |
| Z-0208-2014 Class II | Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A+ Infusion Systems…Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following… | 02/05/2012Terminated |
| Z-0207-2014 Class II | Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A+ Infusion Systems…Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following… | 02/05/2012Terminated |
| Z-0206-2014 Class II | Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: The Plum A+ Infusion…Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following… | 02/05/2012Terminated |
| Z-0205-2014 Class II | Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A+ Infusion Systems…Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following… | 02/05/2012Terminated |
| Z-0204-2014 Class II | Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A+ Infusion Systems…Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following… | 02/05/2012Terminated |
| Z-0203-2014 Class II | Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+…Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following… | 02/05/2012Terminated |
| Z-0817-2012 | Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical…Silicone applied to the piercing pin of the blood set is reducing retention force of the piercing pin while… | 01/12/2012Terminated |
| Z-0596-2012 | 0.9% Sodium Chloride Injection, USP, pre-filled flush solution, for IV Flush only…There is particulate matter in the fluid pathway, which has been identified as the same material as the… | 11/18/2011Terminated |
| Z-0292-2012 | Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave…The float valve in the burette sticks to the burette wall and does not open or close properly. | 11/10/2011Terminated |
| Z-3286-2011 | Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045…Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If… | 09/16/2011Terminated |
| Z-3285-2011 | Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps…Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If… | 09/16/2011Terminated |
| Z-3284-2011 | Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps…Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If… | 09/16/2011Terminated |
| Z-0011-2012 | Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045…Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the… | 09/16/2011Terminated |
| Z-0010-2012 | Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps…Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the… | 09/16/2011Terminated |
| Z-0009-2012 | Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps…Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the… | 09/16/2011Terminated |
| Z-3107-2011 | GemStar Li-Ion Docking Station; a lithium ion battery powered docking station for use…Hospira has received reports of sparking, smoking, charring and electrical shock when using the GemStar… | 08/01/2011Terminated |
| Z-2027-2011 | Hospira Primary Microbore Gemstar Split Set, Integral PAV, Yellow Striped Tubing, 110…There is a potential for the air filter at the distal end of the set to become detached. This could result… | 03/28/2011Terminated |
| Z-2026-2011 | Hospira LifeShield Latex-Free HEMA Y-Type Blood Set, Nonvented, 99 Inch with Drip…There is a potential for the air filter at the distal end of the set to become detached. This could result… | 03/28/2011Terminated |
| Z-2025-2011 | Hospira LifeShield Latex-Free HEMA Y-Type Blood Set, Nonvented, 100 Inch with Clave and…There is a potential for the air filter at the distal end of the set to become detached. This could result… | 03/28/2011Terminated |
| Z-2024-2011 | Hospira Latex-Free Blood Secondary Set, 26 Inch with Secure Lock; a sterile Rx tubing…There is a potential for the air filter at the distal end of the set to become detached. This could result… | 03/28/2011Terminated |
| Z-1999-2011 | GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; Hospira…The software enables programming of the GemStar device for a Bolus Lower Lockout Limit outside of the hard… | 03/23/2011Terminated |
| Z-0362-2017 Class II | Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V.…May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen… | 03/16/2011Terminated |
| Z-0361-2017 Class II | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V.…May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen… | 03/16/2011Terminated |
| Z-1646-2011 | Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045…Hospira has received customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which… | 02/14/2011Terminated |
| Z-1645-2011 | Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps…Hospira has received customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which… | 02/14/2011Terminated |
| Z-1644-2011 | Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps…Hospira has received customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which… | 02/14/2011Terminated |
| Z-1602-2011 | Hospira Plum XL3 Micro/Macro with DataPort Infusion Pump, Triple Channel, with a 0.1-999…Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low… | 02/14/2011Terminated |
| Z-1601-2011 | Hospira Plum XL3 Micro/Macro Infusion Pump, Triple Channel, with a 0.1-999 mL/hr flow…Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low… | 02/14/2011Terminated |
| Z-1600-2011 | Hospira Plum XL3 Infusion Pump, Triple Channel; list number 11781Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low… | 02/14/2011Terminated |
| Z-1599-2011 | Hospira Plum XL Micro/Macro with DataPort Infusion Pump, Single Channel, with a 0.1-999…Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low… | 02/14/2011Terminated |
| Z-1598-2011 | Hospira Plum XL Micro/Macro Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow…Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low… | 02/14/2011Terminated |
| Z-1597-2011 | Hospira Plum XL Infusion Pump, Single Channel; list number 11555Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low… | 02/14/2011Terminated |
| Z-1596-2011 | Hospira Power cord use on Symbiq One-Channel infuser and Symbiq Two-Channel infuser.…Complaints of broken, bent or missing prongs, charring, sparks, visible smoke, burnt smell have been… | 10/27/2010Terminated |
| Z-2633-2010 | Gemstar Pump Set with Convertible Pin, Latex-Free set with Attached Pressure-Activated…Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not… | 08/12/2010Terminated |
| Z-2632-2010 | Gemstar Pump Set, LifeShield Latex-Free Pump Set with Orange Polyethylene-Lined Light…Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not… | 08/12/2010Terminated |
| Z-2631-2010 | Gemstar Pump Set, LifeShield Latex-Free Pump Set with Check Valve, Clave Ports, P.A.V.…Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not… | 08/12/2010Terminated |
| Z-2630-2010 | Gemstar Pump Set-SL, Latex-Free Set with Attached Pressure-Activated Anti-Siphon Valve…Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not… | 08/12/2010Terminated |
| Z-2629-2010 | Gemstar Pump Set-SL, Latex-Free Extension Set with Integral Pressure-Activated…Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not… | 08/12/2010Terminated |
| Z-2628-2010 | Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon…Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not… | 08/12/2010Terminated |
| Z-2627-2010 | Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon…Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not… | 08/12/2010Terminated |
| Z-0126-2011 | EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5The EndoTool software did not always provide an audible alert when a blood glucose measurement was due. This… | 07/26/2010Terminated |
| Z-2234-2010 | Hospira Accessory Power Pack; a 4 outlet power strip with a custom pole clamp bracket to…The Power Pack Accessory is not certified to UL 60601 standard or Subject 1363A for relocatable power taps… | 07/02/2010Terminated |
| Z-1895-2010 | Hospira brand Symbiq Two-Channel Infuser; List Number: 16027; Distributed by: Hospira…Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect… | 04/09/2010Terminated |
| Z-1894-2010 | Hospira brand Symbiq One-Channel Infuser; List Number: 16026; Distributed by: Hospira…Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect… | 04/09/2010Terminated |
| Z-2381-2010 | Hospira Inc. Symbiq One- and Two- Channel Infuser, List Numbers 16026 and 16027…If the administrator set is removed prior to the cassette carriage fully opening without closing the… | 03/26/2010Terminated |
| Z-2391-2010 | Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027 Symbiq Two-Channel Infuser…The clamp may not secure to the IV pole and the pump may slip or fall off. The pump may fall on a person or… | 02/22/2010Terminated |
| Z-2390-2010 | Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List…The clamp may not secure to the IV pole and the pump may slip or fall off. The pump may fall on a person or… | 02/22/2010Terminated |
| Z-0128-2011 | Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027 Symbiq Two-Channel Infuser…Hospira has identified motor encoder failures in the Symbiq pumping mechanism that causes the infuser to… | 02/22/2010Terminated |
| Z-0127-2011 | Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List…Hospira has identified motor encoder failures in the Symbiq pumping mechanism that causes the infuser to… | 02/22/2010Terminated |
| Z-0809-2010 | LifeShield Latex-free Primary I.V. Set, convertible P.P. yellow key slide clamp…There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery… | 01/08/2010Terminated |
| Z-0808-2010 | LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced…There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery… | 01/08/2010Terminated |
| Z-1393-2010 | Lifeshield, latex-free, Y-Type Blood Set, yellow key slide clamp, 110 inch, nonvented…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1392-2010 | Lifeshield, latex-free, Y-Type Blood Set, nonvented, 100 inch with CLAVE and secure…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1391-2010 | Lifeshield, latex-free Secondary I.V. Set, convertible pin, 34 inch, piggyback with…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1390-2010 | Lifeshield, latex-free, Secondary I.V. Set, convertible pin, 32 inch, piggyback with…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1389-2010 | Lifeshield, latex-free Secondary I.V. Set, convertible pin, 32 inch, piggyback with…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1388-2010 | Lifeshield, latex-free, Secondary I.V. Set, convertible pin, 32 inch with OPTION-LOK…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1387-2010 | Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, backcheck valve, 3…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1386-2010 | Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, CLAVE Y-site, 15…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1385-2010 | Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, backcheck valve, 3…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1384-2010 | Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, 120 inch, convertible…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1383-2010 | Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, 120 inch, convertible…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1382-2010 | Life shield Latex-Free Primary I.V. Set, yellow key slide clamp, 120 inch, convertible…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1381-2010 | Lifeshield Latex-Free Primary I.V. Set, yellow key slide clamp, MICRODRIP, backcheck…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1380-2010 | Lifeshield Latex-Free Primary I.V. Set, yellow key slide clamp, backcheck valve, 2 CLAVE…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1379-2010 | Lifeshield, latex-free, Primary I.V. Set, convertible pin, 110 inch with removable…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1378-2010 | Lifeshield, latex-free, Primary I.V. Set, convertible pin, 83 inch, MICRODRIP with…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1377-2010 | CONTINUUM, Lifeshield, latex-free, Primary I.V. Set, convertible pin, 112 inch with…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1376-2010 | Lifeshield, latex-free Primary I.V. Set, convertible pin, 83 inch with backcheck valve…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1375-2010 | Latex-free, Primary I.V. Set, convertible pin, 82 inch with OPTION-LOK, 15 drops/mL, a…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1374-2010 | Lifeshield, latex-free, Primary I.V. Set, convertible pin, 100 inch with OPTION-LOK and…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1373-2010 | Lifeshield, latex-free Primary I.V. Set, convertible pin, 110 inch, 0.2 micron filter…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1372-2010 | Life shield, latex-free, Primary I.V. Set, convertible pin, 100 inch with CALV and…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1371-2010 | Lifeshield, latex-free, Primary I.V. Set, convertible pin, 100 inch with backcheck…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1370-2010 | Lifeshield, latex-free Primary I.V. Set, convertible pin, 104 inch with nonphthalate…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1369-2010 | Lifeshield, latex-free Primary I.V. Set, convertible pin, 100 inch with backcheck valve…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1368-2010 | Lifeshield, latex-free Primary I.V. Set, convertible pin, 100 inch with backcheck valve…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1367-2010 | Lifeshield, latex-free Primary I.V. Set, convertible pin, 100 inch with backcheck valve…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1366-2010 | Lifeshield, latex-free Primary I.V. Set, convertible pin, 100 inch with backcheck valve…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1365-2010 | Lifeshield, latex-free, Primary I.V. Set, convertible pin, 100 inch with CLAVE ports and…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1364-2010 | Lifeshield, latex-free Primary I.V. Set, convertible pin, 80 inch with backcheck valve…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1363-2010 | Lifeshield, latex-free Primary I.V. Set, convertible pin, 78 inch with pre-pierced…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1362-2010 | Lifeshield, latex-free Primary I.V. Set, convertible pin, 80 inch with backcheck valve…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1361-2010 | Lifeshield, latex-free Primary I.V. Set, convertible pin, 106 inch with backcheck valve…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1360-2010 | Latex-free, Primary I.V. Set, vented, 73 inch with flashback bulb, 15 drops/mL, a…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1359-2010 | Latex-free, Primary I.V. Set, vented, 78 inch with injection site, 15 drops/mL, a…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1358-2010 | Lifeshield, latex-free Primary I.V. Pump Set with Distal Microbore Patient Line…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1357-2010 | Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1356-2010 | Lifeshield, latex-free Primary I.V. Pump set with Distal Microbore Patient Line and…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1355-2010 | Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line and…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1354-2010 | Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line and…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1353-2010 | Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1352-2010 | Lifeshield, latex-free, Primary I.V. Pump Set with distal microbore patient line and…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1351-2010 | Latex-free, Primary I.V. Pump Set with distal microbore patient line and gravity flow…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1350-2010 | Latex-free, Primary I.V. Pump Set, convertible pin, 105 inch with 2 injection sites, 15…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1349-2010 | Lifeshield, latex-free, Primary I.V. PLUMSET, convertible pin, 103 inch with backcheck…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1348-2010 | Lifeshield, latex-free, Primary I.V. PLUMSET, convertible pin, 113 inch with 2…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |
| Z-1347-2010 | Lifeshield, Primary I.V. Filter Set, yellow key slide clamp, backcheck valve, 2 CLAVE…Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | 11/24/2009Terminated |