Teleflex Medical
Medical device manufacturer in Morrisville, NC.
44510(k) clearances
1PMA approvals
291recalls
Device types
- GAT Suture, Nonabsorbable, Synthetic… 9
- FZP Clip, Implantable 7
- GAM Suture, Absorbable, Synthetic, Polyglycolic… 3
- FMI Needle, Hypodermic, Single Lumen 3
- BTR Tube, Tracheal (W/Wo Connector) 2
- BTT Humidifier, Respiratory Gas, (Direct… 2
- BSP Needle, Conduction, Anesthetic (W/Wo… 2
- EZC Catheter, Coude 2
- NEW Suture, Surgical, Absorbable, Polydioxanone 1
- DQX Wire, Guide, Catheter 1
- BTO Tube, Tracheostomy (W/Wo Connector) 1
- BSO Catheter, Conduction, Anesthetic 1
- GAW Suture, Nonabsorbable, Synthetic… 1
- CBI Tube, Tracheal/Bronchial, Differential… 1
- CCT Applicator (Laryngo-Tracheal), Topical… 1
- BWC Needle, Emergency Airway 1
- CAH Filter, Bacterial, Breathing-Circuit 1
- GCJ Laparoscope, General & Plastic Surgery 1
- HTY Pin, Fixation, Smooth 1
- DYB Introducer, Catheter 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261988 | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureNEW · Special | 07/09/2026SE |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTapeGAT · Traditional | 05/06/2026SE |
| K251054 | Hem-o-lok PurplePlus Large Polymer Ligating ClipsFZP · Traditional | 07/03/2025SE |
| K242495 | LMA Fastrach ETT SUBTR · Traditional | 04/29/2025SE |
| K243553 | QuikClot Control+ Hemostatic DevicePOD · Traditional | 03/18/2025SE |
| K241784 | Arrow® Nitinol WireDQX · Traditional | 09/18/2024SE |
| K233713 | Pilling Tracheostomy TubesBTO · Traditional | 03/22/2024SE |
| K232970 | Hem-o-lok® Ligating ClipsFZP · Traditional | 01/12/2024SE |
| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen…BSO · Traditional | 08/30/2023SE |
| K231924 | EZ-IO Intraosseous Vascular Access SystemFMI · Special | 07/25/2023SE |
| K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)FZP · Special | 04/28/2023SE |
| K222279 | Rusch Intermittent Urethral CathetersEZC · Special | 08/29/2022SE |
| K202492 | EZ-IO Intraosseous Vascular Access SystemFMI · Traditional | 03/22/2021SE |
| K192490 | Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchGAT · Traditional | 03/30/2020SE |
| K193530 | Deklene MAXXGAW · Special | 03/19/2020SE |
| K190026 | Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)BSP · Traditional | 08/21/2019SE |
| K191268 | Force Fiber SutureGAT · Special | 06/11/2019SE |
| K180253 | Sheridan Endobronchial TubesCBI · Traditional | 11/02/2018SE |
| K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…GAT · Traditional | 10/10/2018SE |
| K173321 | StimuQuik 21G x 9cm (3.5) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm…BSP · Traditional | 04/25/2018SE |
| K180588 | FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous DeviceFMI · Traditional | 04/17/2018SE |
| K173596 | Rusch Intermittent Urethral CathetersEZC · Traditional | 01/29/2018SE |
| K172016 | Force Fiber Fusion SutureGAT · Traditional | 10/03/2017SE |
| K161758 | Weck Auto Endo10 Automatic Endoscopic Clip ApplierFZP · Traditional | 09/07/2016SE |
| K153470 | MADgic Laryngo-Tracheal Mucosal Atomization DeviceCCT · Traditional | 08/19/2016SE |
| K133202 | Hem-O-Lok Ligating ClipFZP · Traditional | 12/03/2013SE |
| K132658 | Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, Horizon Ligting ClipsFZP · Traditional | 11/27/2013SE |
| K130405 | Rusch Easycric Emergency Cricothyrotomy SetBWC · Traditional | 11/06/2013SE |
| K112958 | Humid-Vent HepaCAH · Traditional | 09/21/2012SE |
| K100506 | Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures…GAT · Special | 03/10/2010SE |
| K082156 | Adapt Universal Laparoscopic Port, Model 405940, 405912, 40591213GCJ · Special | 09/10/2008SE |
| K070561 | Kmedic Internal/External Fixation DevicesHTY · Abbreviated | 05/25/2007SE |
| K063758 | Choncha Therm Neptune Heated Humifier, Choncha Therm Neptune Heated Humifier…BTT · Traditional | 04/23/2007SE |
| K063778 | Force Fiber Polyethylene Nonabsorbable SutureGAT · Abbreviated | 02/09/2007SE |
| K062914 | Hem-O-Lok Ligation ClipFZP · Traditional | 11/02/2006SE |
| K061736 | Comfort Flo Humidification System and Nasal CannulaBTT · Traditional | 08/18/2006SE |
| K060801 | Dekna-Lok Model BP1000V2LGAM · Traditional | 05/17/2006SE |
| K060519 | Introducer Assembly with Rotator LockDYB · Special | 05/05/2006SE |
| K043205 | Rusch Easy TubeBTR · Traditional | 01/07/2005SE |
| K043258 | Modified TFX Medical Safety Needle with Introducer, Part No. T4634-02KNT · Special | 12/16/2004SE |
| K042141 | Polyglytone 6211 Synthetic Absorbable SutureGAM · Traditional | 09/28/2004SE |
| K040472 | Force Fiber Blue Co-Braided Polyethylene Nonabsorbable Surgical SutureGAT · Special | 03/15/2004SE |
| K033654 | Force FiberGAT · Traditional | 01/15/2004SE |
| K033115 | OrthodekGAM · Traditional | 11/17/2003SE |
PMA approvals
- P180025 MANTA Vascular Closure Device · 02/01/2019 · 14 supplements
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-1127-2022 Class II | (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with…Reports received of torn corrugated breathing tubes. | 04/11/2022Open, Classified |
| Z-1126-2022 Class II | (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex…Reports received of torn corrugated breathing tubes. | 04/11/2022Open, Classified |
| Z-0629-2022 Class I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good…The firm received reports indicating PTD tip separation during use. | 01/11/2022Terminated |
| Z-0628-2022 Class I | 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF…The firm received reports indicating PTD tip separation during use. | 01/11/2022Terminated |
| Z-0627-2022 Class I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing…The firm received reports indicating PTD tip separation during use. | 01/11/2022Terminated |
| Z-0626-2022 Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC…The firm received reports indicating PTD tip separation during use. | 01/11/2022Terminated |
| Z-0625-2022 Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W…The firm received reports indicating PTD tip separation during use. | 01/11/2022Terminated |
| Z-0624-2022 Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF…The firm received reports indicating PTD tip separation during use. | 01/11/2022Terminated |
| Z-0623-2022 Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF…The firm received reports indicating PTD tip separation during use. | 01/11/2022Terminated |
| Z-1294-2021 Class II | RUSCH POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of…Teleflex is voluntarily recalling the products referenced above due to customers reporting that the… | 02/18/2021Open, Classified |
| Z-1298-2021 Class II | PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a…Teleflex is recalling this product due to a lack of assurance of sterility. | 02/12/2021Terminated |
| Z-2922-2020 Class II | Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to…Potential sterility issue | 08/07/2020Terminated |
| Z-2732-2020 Class II | Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The…Breaking at the point of a welded joint | 07/06/2020Terminated |
| Z-2731-2020 Class II | Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The…Breaking at the point of a welded joint | 07/06/2020Terminated |
| Z-2730-2020 Class II | Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The…Breaking at the point of a welded joint | 07/06/2020Terminated |
| Z-2729-2020 Class II | Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The…Breaking at the point of a welded joint | 07/06/2020Terminated |
| Z-2728-2020 Class II | Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The…Breaking at the point of a welded joint | 07/06/2020Terminated |
| Z-2727-2020 Class II | Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage:…Breaking at the point of a welded joint | 07/06/2020Terminated |
| Z-2726-2020 Class II | Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The…Breaking at the point of a welded joint | 07/06/2020Terminated |
| Z-2749-2020 Class II | Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage:…Potential for sterile packaging to be compromised | 06/30/2020Terminated |
| Z-2748-2020 Class II | Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST…Potential for sterile packaging to be compromised | 06/30/2020Terminated |
| Z-2533-2020 Class II | RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040…Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that… | 05/29/2020Terminated |
| Z-1270-2020 Class II | Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K…There is a potential for the device packaging to become compromised; thus, the sterility of the device… | 01/13/2020Terminated |
| Z-1269-2020 Class II | Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440There is a potential for the device packaging to become compromised; thus, the sterility of the device… | 01/13/2020Terminated |
| Z-1117-2020 Class II | Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic SystemThe products are being recalled due to reports of breakage broke at the point of a welded joint either prior… | 01/09/2020Terminated |
| Z-1116-2020 Class II | Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic SystemThe products are being recalled due to reports of breakage broke at the point of a welded joint either prior… | 01/09/2020Terminated |
| Z-1115-2020 Class I | HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414…There is the potential for water to flood the column and enter the circuit under circumstances where an… | 12/13/2019Terminated |
| Z-1114-2020 Class I | HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kitThere is the potential for water to flood the column and enter the circuit under circumstances where an… | 12/13/2019Terminated |
| Z-1113-2020 Class I | HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port…There is the potential for water to flood the column and enter the circuit under circumstances where an… | 12/13/2019Terminated |
| Z-1112-2020 Class I | HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer…There is the potential for water to flood the column and enter the circuit under circumstances where an… | 12/13/2019Terminated |
| Z-0703-2020 Class II | HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The…The tracheal and brochial swivel connectors are incorrectly labeled. | 10/30/2019Terminated |
| Z-2130-2020 Class II | Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The…Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a… | 10/11/2019Open, Classified |
| Z-2129-2020 Class II | Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The…Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a… | 10/11/2019Open, Classified |
| Z-0690-2020 Class II | Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code…The safety cap attached to needles within the needle sets may become dislodged exposing the needle and… | 10/08/2019Open, Classified |
| Z-0689-2020 Class II | Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code…The safety cap attached to needles within the needle sets may become dislodged exposing the needle and… | 10/08/2019Open, Classified |
| Z-0688-2020 Class II | Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code…The safety cap attached to needles within the needle sets may become dislodged exposing the needle and… | 10/08/2019Open, Classified |
| Z-0497-2020 Class II | WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965…Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a… | 10/04/2019Open, Classified |
| Z-0496-2020 Class II | WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic…Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a… | 10/04/2019Open, Classified |
| Z-2318-2019 Class I | Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF…Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector… | 07/30/2019Terminated |
| Z-2317-2019 Class I | Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway managementReported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector… | 07/30/2019Terminated |
| Z-2316-2019 Class I | Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF…Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector… | 07/30/2019Terminated |
| Z-2315-2019 Class I | Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm…Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector… | 07/30/2019Terminated |
| Z-2314-2019 Class I | Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF…Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector… | 07/30/2019Terminated |
| Z-2313-2019 Class I | Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm…Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector… | 07/30/2019Terminated |
| Z-2312-2019 Class I | Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c)…Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector… | 07/30/2019Terminated |
| Z-2311-2019 Class I | Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF…Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector… | 07/30/2019Terminated |
| Z-2086-2019 Class II | Rusch EasyCath KitPotential for product not to be sterile. | 07/01/2019Terminated |
| Z-1766-2019 Class I | Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code…This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product)… | 05/24/2019Terminated |
| Z-1765-2019 Class I | Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway…This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product)… | 05/24/2019Terminated |
| Z-1764-2019 Class I | Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code…This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product)… | 05/24/2019Terminated |
| Z-1763-2019 Class I | Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm…This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product)… | 05/24/2019Terminated |
| Z-1762-2019 Class I | Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c)…This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product)… | 05/24/2019Terminated |
| Z-1761-2019 Class I | Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product…This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product)… | 05/24/2019Terminated |
| Z-1760-2019 Class I | Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product…This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product)… | 05/24/2019Terminated |
| Z-1759-2019 Class I | Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway…This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product)… | 05/24/2019Terminated |
| Z-1912-2019 Class I | Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and…Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal… | 05/10/2019Terminated |
| Z-1686-2019 Class II | RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0The firm received reports indicating that the laser guard foil partially separated and/or slightly detached… | 04/01/2019Terminated |
| Z-1685-2019 Class II | RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0The firm received reports indicating that the laser guard foil partially separated and/or slightly detached… | 04/01/2019Terminated |
| Z-1684-2019 Class II | RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0The firm received reports indicating that the laser guard foil partially separated and/or slightly detached… | 04/01/2019Terminated |
| Z-1683-2019 Class II | RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0The firm received reports indicating that the laser guard foil partially separated and/or slightly detached… | 04/01/2019Terminated |
| Z-1682-2019 Class II | RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0The firm received reports indicating that the laser guard foil partially separated and/or slightly detached… | 04/01/2019Terminated |
| Z-0797-2020 Class III | Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500MThe device label incorrectly states that the device is sterile. This product is an externally applied male… | 02/27/2019Terminated |
| Z-0796-2020 Class III | Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500The device label incorrectly states that the device is sterile. This product is an externally applied male… | 02/27/2019Terminated |
| Z-1975-2019 Class III | RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection deviceThe device labels are not UDI compliant. The missing UDI compliance information on the labelling would not… | 01/14/2019Terminated |
| Z-1974-2019 Class III | RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection deviceThe device labels are not UDI compliant. The missing UDI compliance information on the labelling is not… | 01/14/2019Terminated |
| Z-0846-2019 Class II | Pilling COOLEY SUMP-SUCTION TUBE, REF 351547The internal tip is missing from the device, causing the device to not function as intended. | 01/07/2019Terminated |
| Z-1193-2018 Class II | Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6… | 02/15/2018Terminated |
| Z-0754-2019 Class II | Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm…There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly… | 01/03/2018Terminated |
| Z-0753-2019 Class II | Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm…There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly… | 01/03/2018Terminated |
| Z-0059-2018 Class II | Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic…Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the… | 10/18/2017Terminated |
| Z-0083-2018 Class II | WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML…The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier. | 10/05/2017Terminated |
| Z-3224-2017 Class II | Percuvance 29cm Shaft The Percutaneous Surgical System with 5mm attachments is indicated…For some of the recalled products, the security of the connection between the shaft and the tool tip may be… | 07/19/2017Terminated |
| Z-3223-2017 Class II | Percuvance Scissors Tool Tip The Percutaneous Surgical System with 5mm attachments is…For some of the recalled products, the security of the connection between the shaft and the tool tip may be… | 07/19/2017Terminated |
| Z-3222-2017 Class II | Percuvance Maryland Dissector Tool Tip The Percutaneous Surgical System with 5mm…For some of the recalled products, the security of the connection between the shaft and the tool tip may be… | 07/19/2017Terminated |
| Z-3221-2017 Class II | Percuvance Johans Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments…For some of the recalled products, the security of the connection between the shaft and the tool tip may be… | 07/19/2017Terminated |
| Z-3220-2017 Class II | Percuvance Clip Applier Tool Tip The Percutaneous Surgical System with 5mm attachments…For some of the recalled products, the security of the connection between the shaft and the tool tip may be… | 07/19/2017Terminated |
| Z-3219-2017 Class II | Percuvance Gripper Grasper Tool Tip The Percutaneous Surgical System with 5mm…For some of the recalled products, the security of the connection between the shaft and the tool tip may be… | 07/19/2017Terminated |
| Z-3212-2017 Class II | LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b)…Teleflex Medical is recalling the affected product because there may be missing or incomplete information on… | 07/05/2017Terminated |
| Z-2587-2017 Class II | Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured…Product size listed on the labeling is incorrect. | 05/11/2017Open, Classified |
| Z-2251-2017 Class II | Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device. | 05/09/2017Terminated |
| Z-2130-2017 Class II | INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory | 04/21/2017Terminated |
| Z-2129-2017 Class II | PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter…Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be… | 04/21/2017Terminated |
| Z-2128-2017 Class II | PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter Connector/AccessoryLabeling: The expiration date is not stated on the labeling, there is a potential for expired product to be… | 04/21/2017Terminated |
| Z-2127-2017 Class II | PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter…Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be… | 04/21/2017Terminated |
| Z-1829-2017 Class III | Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.Some of the individual unit packaging (pouches) may be missing the lot number an expiration date. | 03/29/2017Terminated |
| Z-2108-2017 Class II | WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is…Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat… | 03/24/2017Completed |
| Z-1519-2017 Class II | Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132…Labeling error | 01/13/2017Terminated |
| Z-0705-2018 Class II | Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.The pouch may contain the incorrect Rusch Green Lite product size. Pouches that are labeled as containing… | 01/10/2017Terminated |
| Z-0771-2017 Class II | RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx…Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the… | 11/22/2016Terminated |
| Z-0764-2017 Class II | WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC…Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured. | 11/18/2016Terminated |
| Z-0759-2017 Class II | Weck Facial Closure Systems have application in laparoscopic procedures for…The devices wings may become partially detached from the EFx Shield during use. | 11/16/2016Terminated |
| Z-0679-2017 Class II | ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl…Sterility: Due to a potential incomplete seal on the outer sterile package. | 11/08/2016Terminated |
| Z-0678-2017 Class II | OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone…Sterility: Due to a potential incomplete seal on the outer sterile package. | 11/08/2016Terminated |
| Z-0677-2017 Class II | ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl…Sterility: Due to a potential incomplete seal on the outer sterile package. | 11/08/2016Terminated |
| Z-0676-2017 Class II | ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow…Sterility: Due to a potential incomplete seal on the outer sterile package. | 11/08/2016Terminated |
| Z-0675-2017 Class II | ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for:…Sterility: Due to a potential incomplete seal on the outer sterile package. | 11/08/2016Terminated |
| Z-0898-2017 Class II | Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 10/27/2016Terminated |
| Z-0386-2017 Class II | LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 10/27/2016Terminated |
| Z-0385-2017 Class II | LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 10/27/2016Terminated |
| Z-0384-2017 Class II | LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 10/27/2016Terminated |
| Z-0383-2017 Class II | FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 10/27/2016Terminated |
| Z-0382-2017 Class II | FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These products are used for…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 10/27/2016Terminated |
| Z-0381-2017 Class II | LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 10/27/2016Terminated |
| Z-1177-2017 Class II | Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal…Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled… | 10/18/2016Terminated |
| Z-0059-2017 Class II | Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile…The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johans Graspers… | 09/09/2016Terminated |
| Z-0058-2017 Class II | Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile…The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johans Graspers… | 09/09/2016Terminated |
| Z-0044-2017 Class I | Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients…The connector may disconnect from the tracheostomy tube during use. | 08/26/2016Terminated |
| Z-2759-2016 Class II | WECK Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation…Misbranded: Incorrect etching on the device. | 08/24/2016Terminated |
| Z-1938-2016 Class II | Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx…The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm… | 05/05/2016Terminated |
| Z-1582-2016 Class II | Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx…The label on the Tyvek bag is missing. This is used by customers to identify material code, lot number, and… | 03/30/2016Terminated |
| Z-2538-2016 Class II | Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to…Incorrect expiration date was printed on the product label. | 03/24/2016Terminated |
| Z-0886-2016 Class II | Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only…The clip in the applier may be missing a boss. A boss is the part of the clip that is used to hold the clip… | 02/02/2016Terminated |
| Z-2683-2016 Class II | MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4…Cracking may occur at the 15mm and 22mm ISO female connector. | 12/03/2015Terminated |
| Z-2374-2016 Class II | Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture…Cracks may occur at the 15mm and 22mm ISO female connector. | 12/03/2015Terminated |
| Z-0277-2016 Class II | Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the…The defective component can cause gas leakage through the device. This can result in loss of… | 10/14/2015Terminated |
| Z-0246-2016 Class II | Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. | 08/24/2015Terminated |
| Z-0245-2016 Class II | Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only…Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. | 08/24/2015Terminated |
| Z-2370-2015 Class I | HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile.…The double swivel connector may crack or separate on the endobronchial tube. | 06/01/2015Terminated |
| Z-2369-2015 Class I | HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used to aspirate…The double swivel connector may crack or separate on the endobronchial tube. | 06/01/2015Terminated |
| Z-2368-2015 Class I | HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35…The double swivel connector may crack or separate on the endobronchial tube. | 06/01/2015Terminated |
| Z-2367-2015 Class I | HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35…The double swivel connector may crack or separate on the endobronchial tube. | 06/01/2015Terminated |
| Z-1809-2015 Class I | Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver…The intake port may be blocked which can cause the bag to fail to fill. | 05/14/2015Terminated |
| Z-1558-2015 Class II | Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.Customer complaints were received of power to the unit ceasing and the display going blank. | 04/01/2015Terminated |
| Z-1404-2015 Class II | Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx…Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest… | 03/13/2015Terminated |
| Z-1109-2015 Class II | AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1108-2015 Class II | AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1107-2015 Class II | ADAPTOR, 040 HUM, INTL. Product Usage: The Humidifier Adaptor is an accessory which…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1106-2015 Class II | AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1105-2015 Class II | AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1104-2015 Class II | AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1103-2015 Class II | AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1102-2015 Class II | AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1101-2015 Class II | AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1100-2015 Class II | AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1099-2015 Class II | AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1098-2015 Class II | AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1097-2015 Class II | AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1096-2015 Class II | AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier Adaptor is an…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1095-2015 Class II | Hudson RCI Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR…The packages may contain foreign material (black particles). | 01/14/2015Terminated |
| Z-1085-2015 Class II | LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product…The labelling of units from the affected lot indicates that it contains a size 5 LMA Supreme (New Cuff), but… | 01/13/2015Terminated |
| Z-1051-2015 Class I | MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8…Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female… | 01/12/2015Terminated |
| Z-1078-2015 Class II | Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile…Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct… | 01/09/2015Terminated |
| Z-1178-2016 Class II | Pilling Modular Verres Body/Obturator, Product Code 140880Packaging error in which customers who ordered product code 140880 (Verres cannula for use with a separately… | 01/08/2015Terminated |
| Z-0826-2015 Class II | WECK Hemoclip Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are…The manufacturing dates and expiration dates were transposed on the Tyvek label. | 12/03/2014Terminated |
| Z-0799-2015 Class II | Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle…Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may… | 11/12/2014Terminated |
| Z-0039-2018 Class II | Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF…The knife handles slot depth is out of specification, so blades may not fit on the handles properly. | 09/26/2014Completed |
| Z-2714-2014 Class I | Hudson RCI Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product…The pediatric breathing circuits can crack prior to and during use. | 09/08/2014Terminated |
| Z-2661-2014 Class II | Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These…Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber… | 09/04/2014Terminated |
| Z-0505-2015 Class II | Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070…Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility… | 09/03/2014Terminated |
| Z-0504-2015 Class II | Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL…Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the sterility… | 09/03/2014Terminated |
| Z-2154-2014 Class III | RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx…Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is… | 07/10/2014Terminated |
| Z-2119-2014 Class II | Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a…Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates the correct… | 07/09/2014Terminated |
| Z-2108-2014 Class II | Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx…The temperature probe does not properly connect to the temperature port. | 07/09/2014Terminated |
| Z-2107-2014 Class II | Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas…The temperature probe does not properly connect to the temperature port. | 07/09/2014Terminated |
| Z-2130-2014 Class II | RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile…There is a possibility the handle of the laryngoscope may heat up and melt the end cap. | 06/30/2014Terminated |
| Z-2017-2014 Class II | Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2016-2014 Class II | Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor.The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2015-2014 Class II | Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2014-2014 Class II | Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2013-2014 Class II | Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2012-2014 Class II | Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2011-2014 Class II | Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas humidifier…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2010-2014 Class II | Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2009-2014 Class II | Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2008-2014 Class II | Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory gas…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2007-2014 Class II | Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2006-2014 Class II | Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2005-2014 Class II | Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2004-2014 Class II | Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas…The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | 06/05/2014Terminated |
| Z-2003-2014 Class II | Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas…The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect… | 06/05/2014Terminated |
| Z-1851-2014 Class II | RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical…Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the accompanying… | 05/23/2014Terminated |
| Z-1732-2014 Class II | RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical…Product was packaged with a straight catheter rather than the correct coude (curved) catheter. | 05/21/2014Terminated |
| Z-1786-2014 Class II | Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the…Several complaints were received for the metal support tube missing from the cholangiogram catheter. | 05/16/2014Terminated |
| Z-0419-2016 Class II | Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult…Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed. | 04/17/2014Terminated |
| Z-1561-2014 Class II | Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture…Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached… | 03/11/2014Terminated |
| Z-1560-2014 Class II | Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel…Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached… | 03/11/2014Terminated |
| Z-1559-2014 Class II | Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park…Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached… | 03/11/2014Terminated |
| Z-1558-2014 Class II | Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic…Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached… | 03/11/2014Terminated |
| Z-1557-2014 Class II | Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile…Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached… | 03/11/2014Terminated |
| Z-1556-2014 Class II | Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile…Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached… | 03/11/2014Terminated |
| Z-1555-2014 Class II | Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated…Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached… | 03/11/2014Terminated |
| Z-1535-2014 Class II | Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic…The product did not meet minimum and/or average minimum Teleflex resorption strength requirements. | 03/11/2014Terminated |
| Z-1534-2014 Class II | CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm)…The product did not meet minimum and/or average minimum Teleflex resorption strength requirements. | 03/11/2014Terminated |
| Z-1509-2014 Class II | Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48Product does not meet minimum knot tensile strength requirements. | 03/11/2014Terminated |
| Z-1497-2014 Class II | Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2…The products are being recalled because they did not meet minimum diameter requirements. | 03/11/2014Terminated |
| Z-1328-2014 Class II | 5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No.…Complaints of leakage of insufflation gas through the device. | 03/11/2014Terminated |
| Z-1327-2014 Class II | 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An…Complaints of leakage of insufflation gas through the device. | 03/11/2014Terminated |
| Z-1326-2014 Class II | 5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista…Complaints of leakage of insufflation gas through the device. | 03/11/2014Terminated |
| Z-1325-2014 Class II | 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R…Complaints of leakage of insufflation gas through the device. | 03/11/2014Terminated |
| Z-1324-2014 Class II | 10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog…Complaints of leakage of insufflation gas through the device. | 03/11/2014Terminated |
| Z-1323-2014 Class II | Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck…Complaints of leakage of insufflation gas through the device. | 03/11/2014Terminated |
| Z-1296-2014 Class II | Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable…The products are being recalled because they did not meet minimum needle attachment strength requirements. | 03/11/2014Terminated |
| Z-1295-2014 Class II | Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only…The products are being recalled because they did not meet minimum needle attachment strength requirements. | 03/11/2014Terminated |
| Z-1294-2014 Class II | Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage:…The products are being recalled because they did not meet minimum needle attachment strength requirements. | 03/11/2014Terminated |
| Z-1293-2014 Class II | Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage:…The products are being recalled because they did not meet minimum needle attachment strength requirements. | 03/11/2014Terminated |
| Z-1292-2014 Class II | Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage:…The products are being recalled because they did not meet minimum needle attachment strength requirements. | 03/11/2014Terminated |
| Z-1291-2014 Class II | Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage:…The products are being recalled because they did not meet minimum needle attachment strength requirements. | 03/11/2014Terminated |
| Z-1290-2014 Class II | 5/10/12 Weck Vista" Universal Balloon Open Access Port Long Length (100mm), Product…Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or… | 03/11/2014Terminated |
| Z-1289-2014 Class II | 5/10/12 Weck Vista" Universal Balloon Open Access Port Standard Length (70mm), Product…Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or… | 03/11/2014Terminated |
| Z-1288-2014 Class II | 5/10 Weck Vista" Universal Balloon Open Access Port Short Length (53mm), Product Usage:…Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or… | 03/11/2014Terminated |