Set, I.V. Fluid Transfer
FDA product code LHI · Class II (moderate risk) · 21 CFR 880.5440 · General Hospital
206510(k) clearances
0PMA approvals
51recalls
Manufacturers
- Baxter Healthcare Corp 12
- Medimop Medical Projects, Ltd. 11
- B. Braun Medical, Inc. 9
- Yukon Medical, LLC 8
- Carmel Pharma Ab. 7
- Baxa Corp., Sub. of Cook Group, Inc. 7
- Laboratorios Grifols, S.A. 7
- Abbott Laboratories 5
- West Pharma. Services IL, Ltd. 5
- Acacia, Inc. 5
- Hangzhou Qiantang Longyue Biotechnology Co., Ltd. 4
- Healthtek, Inc. 4
- Excel Medical, Inc. 4
- Baxa Corporation 3
- Medsource International, LLC 3
- Mcgaw, Inc. 3
- B. Braun of America, Inc. 3
- Sfm Medical Devices GmbH 3
- Duoject Medical Systems, Inc. 3
- Lyphomed, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252987 | ADRx Admixture DeviceLHI · Traditional | Epic Medical Pte. , Ltd. | 06/12/2026SE |
| K260301 | Vial AdapterLHI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 06/05/2026SE |
| K250345 | Medline Bag DecanterLHI · Traditional | Medline Industries, LP | 10/24/2025SE |
| K251715 | FlowArt® Vial Access Device VentedLHI · Traditional | Asset Medikal | 10/14/2025SE |
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II…LHI · Traditional | Microtek Medical, LLC | 09/16/2025SE |
| K243404 | HyHub and HyHub Duo Vial Access DevicesLHI · Traditional | Takeda Pharmaceuticals | 07/18/2025SE |
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060)LHI · Traditional | Yukon Medical, LLC | 03/21/2025SE |
| K243985 | Rio Drug Reconstitution Transfer DeviceLHI · Traditional | Icu Medical, Inc. | 01/22/2025SE |
| K243486 | SmartSiteTM Vented Vial Access DeviceLHI · Traditional | Yukon Medical, LLC | 12/06/2024SE |
| K241976 | nextaro® va, 15mm, 5µmLHI · Special | Sfm Medical Devices GmbH | 09/06/2024SE |
| K233287 | Vent Vial AdapterLHI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 07/26/2024SE |
| K232987 | FlowArt Valve for Vial AccessLHI · Traditional | Asset Medikal Tasarim Sanayi VE Ticaret A.S. | 06/26/2024SE |
| K240940 | Vial2Bag Advanced® 20mm Admixture DeviceLHI · Special | West Pharmaceutical Services, Inc. | 05/03/2024SE |
| K233284 | Vial Adapter with FilterLHI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 05/01/2024SE |
| K240748 | nextaro® v, 20/20LHI · Special | Sfm Medical Devices GmbH | 04/16/2024SE |
| K233021 | BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access DeviceLHI · Traditional | Care Fusion | 03/06/2024SE |
| K231071 | Mix2Vial® Transfer DeviceLHI · Traditional | West Pharma. Services IL, Ltd. | 01/19/2024SE |
| K232875 | Vial Adapter 20mmLHI · Traditional | West Pharma. Services IL, Ltd. | 12/14/2023SE |
| K230988 | Vial2Bag Advanced® 13mm Admixture DeviceLHI · Traditional | West Pharma. Services IL, Ltd. | 12/01/2023SE |
| K232055 | Vial AdapterLHI · Traditional | Shanghai Lingfu Technology Co., Ltd. | 10/06/2023SE |
| K230464 | MixJect® Transfer DeviceLHI · Traditional | West Pharma. Services IL, Ltd. | 05/22/2023SE |
| K222718 | Vial AdapterLHI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 03/10/2023SE |
| K213513 | Vented Vial Adapter 20mmLHI · Traditional | West Pharma. Services IL, Ltd. | 08/31/2022SE |
| K212525 | Advcare Vial Direct to Bag (VDB) Needle-free Admixture DevicesLHI · Traditional | Advcare Medical | 08/19/2022SE |
| K220856 | Vial Adapter Ø13mmLHI · Traditional | Avenir Performance Européenne Medical (Apem) | 06/21/2022SE |
| K212445 | freeflex+ Transfer AdapterLHI · Traditional | Fresenius Kabi AG | 06/01/2022SE |
| K212530 | IVX Fluid Transfer SetLHI · Traditional | Omnicell, Inc. | 04/24/2022SE |
| K202732 | SOL-CARE IV Bag Safety ConnectorLHI · Traditional | Sol-Millennium Medical Group | 11/03/2021SE |
| K203674 | B Dispensing LineLHI · Traditional | Aea Srl | 09/27/2021SE |
| K200893 | ProntoPump Sterile Tube SetLHI · Traditional | Ipax, Inc. | 05/04/2021SE |
| K201469 | Mini Spike Plus 6/8RLHI · Traditional | B.Braun Medical, Inc. | 12/09/2020SE |
| K201415 | Vial2Bag Advanced 20mm Admixture DeviceLHI · Traditional | West Pharmaceutical Services Az, Inc. | 10/21/2020SE |
| K192154 | Rio Vial-to-Bag Drug Reconstitution DeviceLHI · Traditional | Icu Medical | 04/20/2020SE |
| K182819 | Decanting DeviceLHI · Traditional | Gcmedica Enterprise Ltd.(Wuxi) | 12/02/2019SE |
| K190816 | Vial Adapter Ø20 mm , Vial Adapter Ø13 mmLHI · Traditional | Avenir Performance Europeenne Medical (Apem) | 11/19/2019SE |
| K190149 | Vial Adapter Ø20 mmLHI · Traditional | Avenir Performance Europeenne Medical (Apem) | 10/15/2019SE |
| K183187 | nextaro Transfer System, nextaro vaLHI · Traditional | Sfm Medical Devices GmbH | 03/15/2019SE |
| K173577 | Guarded Luer ConnectorLHI · Traditional | International Medical Industries, Inc. | 06/07/2018SE |
| K162216 | Gri-Fill Peristaltic SetLHI · Abbreviated | Laboratorios Grifols, S.A. | 10/19/2017SE |
| K171796 | Vial Adapter 15mmLHI · Special | Medimop Medical Project , Ltd. | 10/12/2017SE |
| K172884 | Arisure Closed Vial AdapterLHI · Traditional | Yukon Medical | 10/03/2017SE |
| K172631 | Arisure Dry SpikeLHI · Traditional | Yukon Medical | 09/29/2017SE |
| K170095 | Vial2Bag Direct ConnectLHI · Special | Medimop Medical Project , Ltd. | 03/08/2017SE |
| K161800 | OnSite-IVLHI · Traditional | Pharmc, LLC | 12/06/2016SE |
| K160503 | Vented Vial Adapter Transfer Device - 13mmLHI · Special | Medimop Medical Projects, Ltd. | 05/04/2016SE |
| K151423 | APEX Compounding System Transfer SetLHI · Traditional | B.Braun Medical, Inc. | 02/19/2016SE |
| K152441 | KIRO SetLHI · Traditional | Kiro Robotics S.L. | 12/04/2015SE |
| K150787 | Universal SpikeLHI · Traditional | B.Braun Medical, Inc. | 12/02/2015SE |
| K151963 | SmartSite Vented Vial Access DeviceLHI · Traditional | Yukon Medical, LLC | 07/31/2015SE |
| K142600 | VIAL-MATE AdaptorLHI · Special | Baxter Healthcare Corporation | 11/19/2014SE |
| K140730 | VIAL2BAG Direct ConnectLHI · Traditional | Medimop Medical Projects, Ltd. | 06/12/2014SE |
| K140442 | Medsource Selectable IV SetLHI · Special | Medsource International, LLC | 04/22/2014SE |
| K140402 | Medsource IV Administration Set 72 Medsource IV Administration Set, Needleless Male…LHI · Special | Medsource International, LLC | 04/03/2014SE |
| K133097 | E-Z LinkLHI · Traditional | Duoject Medical Systems, Inc. | 03/13/2014SE |
| K133602 | Add-Vantage AddaptorLHI · Traditional | Hospira, Inc. | 01/24/2014SE |
| K131646 | Disposable Infusion SetLHI · Traditional | Shanghai Jinta Medical Co., Ltd. | 11/26/2013SE |
| K132863 | Smartsite VialshieldLHI · Traditional | Yukon Medical, LLC | 10/04/2013SE |
| K130179 | MP Vial Adapter 13MMLHI · Traditional | Medimop Medical Projects, Ltd. | 08/08/2013SE |
| K132040 | Vial Connector 13MM Closed CollarLHI · Special | Medimop Medical Projects, Ltd. | 07/31/2013SE |
| K120384 | Protector, Injector, ConnectorLHI · Traditional | Bd Medical-Medical Surgical Systems | 09/12/2012SE |
| K122265 | Vialok Single Vial Access Device VentedLHI · Traditional | Yukon Medical, LLC | 08/14/2012SE |
| K120424 | Medsource IV Adminstration SetLHI · Traditional | Medsource International, LLC | 07/11/2012SE |
| K120150 | Dual Spike Transfer DeviceLHI · Traditional | B.Braun Medical, Inc. | 05/24/2012SE |
| K121182 | Vialok Non-VentedLHI · Traditional | Yukon Medical, LLC | 05/03/2012SE |
| K111577 | Medline Vial DecanterLHI · Traditional | Medline Industries, Inc. | 09/08/2011SE |
| K110023 | Infusion Adapter C100LHI · Traditional | Carmel Pharma Ab. | 04/12/2011SE |
| K102590 | Fleboset DoubleLHI · Abbreviated | Laboratorios Grifols, S.A. | 01/13/2011SE |
| K101940 | Equashield System Protective PlusLHI · Traditional | Equashield Medical , Ltd. | 11/19/2010SE |
| K101309 | Exelint Aluminum Hub Blunt NeedlesLHI · Traditional | Exelint International, Co. | 10/20/2010SE |
| K100640 | 20 Mmvial Fluid Transfer Adapter, Model 7E2500LHI · Traditional | B.Braun Medical, Inc. | 07/22/2010SE |
| K090917 | Sureconnect Closed Drug Reconstitution and Transfer SystemLHI · Traditional | Baxa Corp. | 02/19/2010SE |
| K093182 | Set Gri-Fill 3.0LHI · Abbreviated | Laboratorios Grifols, S.A. | 01/27/2010SE |
| K092782 | Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35C…LHI · Traditional | Carmel Pharma Ab. | 12/07/2009SE |
| K092246 | Nipro Needleless Transfer Device, Models: M285503 and M285505LHI · Traditional | Nipro Medical Corporation | 11/12/2009SE |
| K092318 | Baxject II Hi-Flow Needleless Transfer DeviceLHI · Traditional | Baxter Healthcare Corporation | 10/30/2009SE |
| K091389 | Equalshield Luer Lock Connector PairLHI · Special | Plastmed, Ltd. | 10/22/2009SE |
| K083851 | Inviroblunt Cannula with and Without Ez Wings, Models 120522 and 120022LHI · Special | Inviro Medical Devices, Inc. | 05/15/2009SE |
| K090905 | Addease 20MM Binary Connector with 17 Ga. NeedleLHI · Special | B.Braun Medical, Inc. | 04/27/2009SE |
| K090634 | Phaseal Protector P14, P21, P28 and P50LHI · Special | Carmel Pharma Ab. | 03/23/2009SE |
| K083152 | Equashield SystemLHI · Traditional | Plastmed, Ltd. | 02/02/2009SE |
| K080976 | Nexus I.V. Fluid Transfer DeviceLHI · Traditional | Nexus Medical, LLC | 11/10/2008SE |
| K082752 | QuickpinLHI · Traditional | Laboratorios Grifols, S.A. | 09/29/2008SE |
| K080174 | Phlebotomy Bag with Valve & 17G X 1, Model CM-PH17X1B, CM-PH17X1CLHI · Traditional | Cardio Med Supplies, Inc. | 04/23/2008SE |
| K070584 | Smart-RodLHI · Traditional | Duoject Medical Systems, Inc. | 04/02/2008SE |
| K072759 | VIAL2BAGLHI · Abbreviated | Medimop Medical Projects, Ltd. | 12/13/2007SE |
| K072511 | Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MMLHI · Abbreviated | Medimop Medical Projects, Ltd. | 12/13/2007SE |
| K071741 | Tevadaptor, Closed Drug Reconstitution and Transfer SystemLHI · Traditional | Migada Plant | 09/24/2007SE |
| K062482 | Vented Vial Adapter Transfer DeviceLHI · Traditional | Medimop Medical Projects, Ltd. | 11/03/2006SE |
| K060866 | Phaseal - Closed System for the Preparation and Administration of Parenteral DrugsLHI · Special | Carmel Pharma Ab. | 04/28/2006SE |
| K052790 | Smartsite Vented Vial Access Device, Model TBDLHI · Traditional | Cardinal Health, Alaris Products | 12/23/2005SE |
| K051669 | Tevadaptor Closed Drug Reconstitution and Transfer SystemLHI · Traditional | Migada Plant | 09/01/2005SE |
| K050339 | Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleLHI · Traditional | Laboratorios Grifols, S.A. | 02/25/2005SE |
| K043304 | Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01LHI · Traditional | Bioject Medical Technologies, Inc. | 01/14/2005SE |
| K041222 | Pinnacle TPN Management System Transfer SetLHI · Traditional | B.Braun Medical, Inc. | 10/14/2004SE |
| K042410 | Baxject IILHI · Abbreviated | Baxter Healthcare Corp | 10/08/2004SE |
| K041691 | Clip 'N'Ject Reconstitution System (Clip 'N'JectLHI · Traditional | West Pharmaceutical Services, Inc. | 08/05/2004SE |
| K041232 | Gettig Universal Vial Access PinLHI · Traditional | Gettig Pharmaceutical Instrument Co. | 07/22/2004SE |
| K041564 | Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01LHI · Traditional | Bioject Medical Technologies, Inc. | 07/16/2004SE |
| K040634 | Robertsite Vial Adapter, Model 245700021LHI · Traditional | Halkey-Roberts Corp. | 03/23/2004SE |
| K040456 | Fleboset MultipleLHI · Traditional | Laboratorios Grifols, S.A. | 03/09/2004SE |
| K033682 | Set Gri-Fill 2.0-1 Way; 2.0-2 Ways; Luer Connection TubeLHI · Traditional | Laboratorios Grifols, S.A. | 12/17/2003SE |
| K031861 | MIX2VIAL Transfer DeviceLHI · Traditional | Medimop Medical Projects, Ltd. | 07/29/2003SE |
| K024239 | Chemo Dispensing Pin, Model 12495LHI · Special | Abbott Laboratories | 01/13/2003SE |
| K023539 | Steri-Spouts; Bag-Spout, Vial-Spout, Transfer Mixer; Rapidflow, Vialflow, TransflowLHI · Traditional | Valumed | 12/17/2002SE |
| K023747 | PhasealLHI · Special | Carmel Pharma Ab. | 11/15/2002SE |
| K022523 | Rapid-Fill Tubeset, Model 90005LHI · Traditional | Baxa Corp. | 08/12/2002SE |
| K012189 | Angeltouch Vented IV Administration SetLHI · Traditional | Angiplast Private , Ltd. | 03/05/2002SE |
| K013523 | Cistem Fluid Transfer Device, Model 7S2012 and 7S2013LHI · Traditional | Shire Biologics, Inc. | 01/07/2002SE |
| K013087 | Single Dose Dispensing Pin, Model 2201LHI · Traditional | Alaris Medical Systems, Inc. | 11/13/2001SE |
| K010703 | Inter-VialLHI · Traditional | Duoject Medical Systems, Inc. | 06/25/2001SE |
| K010623 | Reconstitution Kit & Vial ConnectorLHI · Traditional | Bioject, Inc. | 04/05/2001SE |
| K002705 | Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400LHI · Traditional | Baxa Corp. | 03/28/2001SE |
| K003730 | Chemo-Aide Dispensing PinLHI · Traditional | Baxter Healthcare Corp | 12/20/2000SE |
| K001831 | Needleless Transfer DeviceLHI · Traditional | Medimop Medical Projects, Ltd. | 07/11/2000SE |
| K001368 | Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion AdapterLHI · Special | Carmel Pharma Ab. | 05/12/2000SE |
| K001293 | Modification to Mixject Dispensing Pin/With Detachable Vial Holder/With Detachable Vial…LHI · Special | Medimop Medical Projects, Ltd. | 05/05/2000SE |
| K994323 | Kawasumi Laboratories Philebotomy SetLHI · Traditional | Kawasumi Laboratories Co., Ltd. | 03/08/2000SE |
| K000367 | SecurmixLHI · Traditional | Eurospital | 02/29/2000SE |
| K990711 | Codan ChemospikeLHI · Traditional | Codan US Corp. | 04/13/1999SE |
| K983794 | Chemo Mini Spike PlusLHI · Traditional | B. Braun of America, Inc. | 03/23/1999SE |
| K980587 | IV Decanter-FlexibleLHI · Traditional | Inrad | 04/17/1998SE |
| K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration…LHI · Traditional | Carmel Pharma Ab. | 03/03/1998SE |
| K974431 | Chemo-Spike II Reconstitution DeviceLHI · Traditional | Medi-Dose, Inc. | 01/08/1998SE |
| K974198 | Taky-Spike PlusLHI · Traditional | Clinico | 12/22/1997SE |
| K973654 | Vial-Mate Reconstitution Device (2B8071)LHI · Traditional | Baxter Healthcare Corp | 10/24/1997SE |
| K961008 | Automix 3+3/AS Compounder SystemLHI · Traditional | Baxter Healthcare Corp | 10/10/1997SE |
| K972134 | Bag DecanterLHI · Traditional | Remington Medical, Inc. | 08/26/1997SE |
| K972117 | Msi Bottleflow, Transflow, VialflowLHI · Traditional | Medical Specialty Innovations, Inc. (Msi) | 08/26/1997SE |
| K955622 | Automix Plus, 3+3, Micromix Compounding System;LHI · Traditional | Baxter Healthcare Corp | 05/06/1997SE |
| K970789 | Safe-Connect Vial Dispensing SpikeLHI · Traditional | Faulding Medical Device Co. | 05/01/1997SE |
| K964989 | CDC Vial and Bag Access Pin (CDC-P-1/P-2/P-3/P-4/P-5)LHI · Traditional | Critical Device Corp. | 04/02/1997SE |
| K970359 | Combiprot Emergency Enfusion DeviceLHI · Traditional | B.Braun Medical, Inc. | 03/18/1997SE |
| K963012 | Bioject Needle-Free Vial Adapter (13MM)LHI · Traditional | Bioject, Inc. | 10/15/1996SE |
| K963583 | Mixject Dispensing Pin/With Detachable Vial Holder/With Detachable Vial Holder and…LHI · Traditional | Medimop Medical Projects, Ltd. | 10/07/1996SE |
| K960466 | IVEX-2 Extension Set with Y-Injection Site (Modification)LHI · Traditional | Abbott Laboratories | 05/29/1996SE |
| K960921 | Codan Medlon BC110 Vial Adapter Codan SpikeLHI · Traditional | Codan Medlon, Inc. | 04/17/1996SE |
| K955398 | Formulation Preparation DeviceLHI · Traditional | B.Braun Medical, Inc. | 04/04/1996SE |
| K955595 | Safeline Multidose Vial AdapterLHI · Traditional | Mcgaw, Inc. | 03/06/1996SE |
| K955594 | Safeline I.V. Bag Access DeviceLHI · Traditional | Mcgaw, Inc. | 03/06/1996SE |
| K955896 | Macrobore Tubing - CDC-F-1 Through CDC-F-11LHI · Traditional | Critical Device Corp. | 02/06/1996SE |
| K950305 | Qtmicro(Tm) SystemLHI · Traditional | Q.I. Medical, Inc. | 10/13/1995SE |
| K943095 | IV Transfer SpikeLHI · Traditional | Migada, Ltd. | 09/30/1994SE |
| K943181 | Dispensing Pin with One-Way ValveLHI · Traditional | B. Braun of America, Inc. | 09/29/1994SE |
| K935532 | Transfer SetLHI · Traditional | Puritas Health Care, Inc. | 04/04/1994SE |
| K935274 | Diprivan Luer ConnectorLHI · Traditional | Ohmeda Medical | 03/15/1994SE |
| K926071 | Onco-Vial AdapterLHI · Traditional | David Bull Laboratories, USA, Inc. | 02/14/1994SE |
| K932462 | Vented NeedleLHI · Traditional | Excel Medical, Inc. | 09/15/1993SE |
| K923782 | Transfer SetLHI · Traditional | Pacific Device, Inc. | 07/02/1993SE |
| K923966 | Syringe AdaptorLHI · Traditional | Excel Medical, Inc. | 06/18/1993SE |
| K924064 | Interlink Universal Vial AdapterLHI · Traditional | Baxter Healthcare Corp | 04/21/1993SE |
| K925401 | IV Fluid Transfer PinLHI · Traditional | B. Braun of America, Inc. | 03/03/1993SE |
| K920015 | Quicktest SystemLHI · Traditional | Q.I. Medical, Inc. | 11/23/1992SE |
| K921031 | Edge Medical Dispensing PinLHI · Traditional | Edgewater Medical Center | 10/19/1992SE |
| K921365 | Nutrimix MicrocompounderLHI · Traditional | Abbott Laboratories | 06/30/1992SE |
| K913985 | Transfer-Aid(Tm)LHI · Traditional | Healthtek, Inc. | 03/18/1992SE |
| K912771 | Acacias Pharm/PumpLHI · Traditional | Acacia, Inc. | 02/14/1992SE |
| K913804 | Excelsior Single Lead Dispensing SetLHI · Traditional | Excel Medical, Inc. | 02/11/1992SE |
| K902853 | Gravity Plus Controller/CompounderLHI · Traditional | Fergy Corp. | 05/09/1991SE |
| K905116 | Pharm-AssistLHI · Traditional | Excel Medical, Inc. | 04/25/1991SE |
| K910213 | Nutrimix(R) Macro(Tm) TPN Compounder/ModificationLHI · Traditional | Abbott Laboratories | 04/16/1991SE |
| K910793 | Reconstitution DeviceLHI · Traditional | Baxter Healthcare Corp | 03/21/1991SE |
| K905201 | TPN Fluid Transfer SetLHI · Traditional | Mcgaw, Inc. | 01/02/1991SE |
| K904855 | Add-A-VialLHI · Traditional | Kendall Mcgaw Laboratories, Inc. | 11/19/1990SE |
| K903159 | Valve Controller for Micromacro CompounderLHI · Traditional | Baxa Corp., Sub. of Cook Group, Inc. | 11/07/1990SE |
| K904225 | KwikmixLHI · Traditional | Baxa Corp., Sub. of Cook Group, Inc. | 11/05/1990SE |
| K895922 | Metricare Empty Container SystemsLHI · Traditional | Metrix Co. | 08/22/1990SE |
| K900865 | Add-A-Vial II Binary ConnectorLHI · Traditional | Kendall Mcgaw Laboratories, Inc. | 07/11/1990SE |
| K901063 | Luer Lock Transfer PinLHI · Traditional | Acacia, Inc. | 07/06/1990SE |
| K902482 | Vitalmix (Set & Bag)LHI · Traditional | Pacific Device, Inc. | 07/02/1990SE |
| K901404 | Nutrimix Macro TPN CompounderLHI · Traditional | Abbott Laboratories | 06/26/1990SE |
| K900585 | Tubing Sets for Baxa Exacta-Med Pharmacy PumpLHI · Traditional | Baxa Corp., Sub. of Cook Group, Inc. | 04/18/1990SE |
| K896990 | PharmulatorLHI · Traditional | Acacia, Inc. | 03/23/1990SE |
| K890205 | Automix Compounder Y - Adaptor SetLHI · Traditional | Stedim, Inc. | 10/27/1989SE |
| K890204 | Automix Compounder Vented Spike AdaptorLHI · Traditional | Stedim, Inc. | 10/27/1989SE |
| K894827 | Automix 3+3 CompounderLHI · Traditional | Baxter Healthcare Corp | 10/06/1989SE |
| K884626 | Modified Sliding Reconstitution DeviceLHI · Traditional | Baxter Healthcare Corp | 11/22/1988SE |
| K874495 | Adcomp 4000 HP SystemLHI · Traditional | Healthtek, Inc. | 02/16/1988SE |
| K872446 | Modified InstafilLHI · Traditional | Instafil, Inc. | 08/25/1987SE |
| K860610 | AdcompLHI · Traditional | Healthtek, Inc. | 07/08/1986SE |
| K860703 | U - Star (Micro-Star)LHI · Traditional | Corning Costar Corp. | 05/06/1986SE |
| K861434 | Modified HC-417 Bag to Bag & HC-418 Bottle to BagLHI · Traditional | Churchill Corp. | 05/01/1986SE |
| K860595 | Transfer SetLHI · Traditional | Migada, Ltd. | 04/07/1986SE |
| K860434 | Chemo-VentLHI · Traditional | Intl. Medical Industries | 02/12/1986SE |
| K860113 | Double-Ject Transfer NeedleLHI · Traditional | Medimix Products, Inc. | 02/12/1986SE |
| K854556 | Transfer NeedleLHI · Traditional | Soma Intl., Inc. | 01/16/1986SE |
| K854008 | StatlockLHI · Traditional | Healthtek, Inc. | 11/13/1985SE |
| K853830 | Sliding Reconstitution Device W/Admix Vialex PlastLHI · Traditional | Travenol Laboratories, S.A. | 11/06/1985SE |
| K852467 | Vial Vent FilterLHI · Traditional | Baxter Healthcare Corp | 10/17/1985SE |
| K853075 | Mednova Safety BagLHI · Traditional | Mednova Corp. | 10/16/1985SE |
| K853212 | Flow Ease(Plastic Vented Needle)LHI · Traditional | Acacia, Inc. | 09/19/1985SE |
| K853188 | Transfer DeviceLHI · Traditional | Advance Medical Designs, Inc. | 08/21/1985SE |
| K852882 | Maxifill Transfer SetLHI · Traditional | Lyphomed, Inc. | 08/16/1985SE |
| K850757 | Tandem Sets I.V.LHI · Traditional | Acacia, Inc. | 04/04/1985SE |
| K850051 | Versa-Fill 120 & Fill Set 42-50LHI · Traditional | Intl. Medical Industries | 03/06/1985SE |
| K844904 | Cytosafe NeedleLHI · Traditional | Baxa Corp., Sub. of Cook Group, Inc. | 02/22/1985SE |
| K843639 | Add-A-Vial Solution Transfer DeviceLHI · Traditional | American Mcgaw | 01/14/1985SE |
| K844340 | Travenol Reconstitution Device W/Admix CapLHI · Traditional | Travenol Laboratories, S.A. | 01/09/1985SE |
| K842345 | Maxifill Transfer SetLHI · Traditional | Lyphomed, Inc. | 08/17/1984SE |
| K834500 | Solution Transfer SetLHI · Traditional | Berlex Laboratories, Inc. | 02/17/1984SE |
| K832347 | Twofer NeedleLHI · Traditional | Baxa Corp., Sub. of Cook Group, Inc. | 09/12/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3212-2026 | CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes:…Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result… | ICU Medical, Inc. | 08/20/2026Open, Classified |
| Z-1532-2025 Class II | IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per…IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended… | Omnicell, Inc. | 02/20/2025Open, Classified |
| Z-0283-2025 Class II | Brand Name: Vial2Bag Advanced Product Name: Vial2Bag Advanced 20mm Admixture Device…Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the… | West Pharmaceutical Services AZ, Inc. | 09/24/2024Open, Classified |
| Z-3085-2024 Class I | Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical…Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated… | Baxter Healthcare Corporation | 08/20/2024Open, Classified |
| Z-3084-2024 Class I | Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a…Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated… | Baxter Healthcare Corporation | 08/20/2024Open, Classified |
| Z-3083-2024 Class I | Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a…Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated… | Baxter Healthcare Corporation | 08/20/2024Open, Classified |
| Z-3082-2024 Class I | Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a…Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated… | Baxter Healthcare Corporation | 08/20/2024Open, Classified |
| Z-1002-2024 Class I | Baxter Exactamix Pro 2400, REF EXM24DYAn error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature… | Baxter Healthcare Corporation | 12/22/2023Open, Classified |
| Z-1001-2024 Class I | Baxter Exactamix Pro 1200, REF EXM12DYAn error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature… | Baxter Healthcare Corporation | 12/22/2023Open, Classified |
| Z-0925-2023 Class II | Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock…Blister package had an unsealed edge compromising sterility. | International Medical Industries, Inc. | 09/16/2022Open, Classified |
| Z-1570-2022 Class II | The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation…There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets. | Baxter Healthcare Corporation | 07/14/2022Open, Classified |
| Z-0727-2022 Class II | Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin…This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the… | B. Braun Medical, Inc. | 01/31/2022Terminated |
| Z-0167-2020 Class II | EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and…Potential ability to leak once used for compounding. | Baxter Healthcare Corporation | 09/18/2019Terminated |
| Z-0769-2019 Class I | Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx OnlyAdverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in… | West Pharma. Services Il, Ltd | 12/26/2018Terminated |
| Z-0768-2019 Class I | Vial2BAG Transfer Device, REF 6070104, Single use only, Rx OnlyAdverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in… | West Pharma. Services Il, Ltd | 12/26/2018Terminated |
| Z-0767-2019 Class I | Vial2BAG DC 13mm, REF 6070111, Single use only, Rx OnlyAdverse events have been reported with the use of oxytocin in conjunction with the product in pregnant… | West Pharma. Services Il, Ltd | 12/26/2018Terminated |
| Z-1911-2018 Class II | Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding…Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were… | Baxter Healthcare Corporation | 04/25/2018Terminated |
| Z-1910-2018 Class II | Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400…Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were… | Baxter Healthcare Corporation | 04/25/2018Terminated |
| Z-1909-2018 Class II | Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400…Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were… | Baxter Healthcare Corporation | 04/25/2018Terminated |
| Z-1908-2018 Class II | Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage:…Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were… | Baxter Healthcare Corporation | 04/25/2018Terminated |
| Z-0972-2018 Class II | Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in…Medimop is recalling certain lots of this product Vial2Bag DC due to the potential of the IV Port separating… | Medimop Medical Projects Ltd. | 10/06/2017Terminated |
| Z-0007-2017 Class I | 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and…Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2… | Baxter Corporation Englewood | 08/24/2016Terminated |
| Z-1907-2016 Class II | Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: Used for…BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units.… | B. Braun Medical, Inc. | 04/14/2016Terminated |
| Z-1906-2016 Class II | Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product…BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units.… | B. Braun Medical, Inc. | 04/14/2016Terminated |
| Z-1963-2014 Class II | EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200…If the universal ingredient (UI) in an active configuration is changed using the Configuration Editor, a… | Baxter Healthcare Corp. | 06/10/2014Terminated |
| Z-2070-2014 Class II | Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead…There is a potential for a leak. A molding defect in the connector that joins the three leads to the main… | Excelsior Medical Corp | 06/05/2014Terminated |
| Z-0392-2014 Class II | Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation…Incomplete foil seal on one lot of sterile product. | Baxter Healthcare Corp. | 09/25/2013Terminated |
| Z-2165-2013 Class II | Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use.…Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due… | Baxa Corporation | 08/22/2013Terminated |
| Z-1752-2013 Class II | ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds…Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary… | Baxa Corporation | 06/04/2013Terminated |
| Z-0425-2014 Class II | 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers…Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and… | B. Braun Medical, Inc. | 04/04/2013Terminated |
| Z-0424-2014 Class II | 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers…Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and… | B. Braun Medical, Inc. | 04/04/2013Terminated |
| Z-3276-2011 | LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare…There is the potential for an order entry error during use of the LOGIX Order Entry (OE) software. When… | Baxter Healthcare Corp. | 08/15/2011Terminated |
| Z-2291-2011 | LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare…The LOGIX OE automated backup does not retain the three most recent backup files and instead will only… | Baxter Healthcare Corp. | 03/29/2011Terminated |
| Z-1967-2011 | ExactaMix EVA Container, 3000mL, REF: 741, Sterile R, Baxa Corporation, Englewood, CO…TPN bags may leak during filling operation, due to bag manufacturing error. | Baxa Corporation | 03/08/2011Terminated |
| Z-1966-2011 | ExactaMix EVA Container, 2000mL, REF: 740, Sterile R, Baxa Corporation, Englewood, CO…TPN bags may leak during filling operation, due to bag manufacturing error. | Baxa Corporation | 03/08/2011Terminated |
| Z-1965-2011 | ExactaMix EVA Container, 1000mL, REF: 739, Sterile R, Baxa Corporation, Englewood, CO…TPN bags may leak during filling operation, due to bag manufacturing error. | Baxa Corporation | 03/08/2011Terminated |
| Z-1964-2011 | ExactaMix EVA Container, 500mL, REF: 738, Sterile R, Baxa Corporation, Englewood, CO…TPN bags may leak during filling operation, due to bag manufacturing error. | Baxa Corporation | 03/08/2011Terminated |
| Z-1963-2011 | ExactaMix EVA Container, 250mL, REF: 737, Sterile R, Baxa Corporation, Englewood, CO…TPN bags may leak during filling operation, due to bag manufacturing error. | Baxa Corporation | 03/08/2011Terminated |
| Z-1962-2011 | ExactaMix EVA Container, Calibration Bag, REF: 735, Sterile R, Baxa Corporation…TPN bags may leak during filling operation, due to bag manufacturing error. | Baxa Corporation | 03/08/2011Terminated |
| Z-1386-2011 | AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated…The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The… | Baxter Healthcare Corp. | 01/27/2011Terminated |
| Z-1385-2011 | AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated…The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The… | Baxter Healthcare Corp. | 01/27/2011Terminated |
| Z-1384-2011 | AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition…The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The… | Baxter Healthcare Corp. | 01/27/2011Terminated |
| Z-1383-2011 | AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders…The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The… | Baxter Healthcare Corp. | 01/27/2011Terminated |
| Z-0306-2011 | B. Braun addEASE Binary Connector, Catalogue #N7993, 200 units (50 units per bag with 4…During this insertion, fragmentation of the PAB container stopper may occur resulting in a small amount of… | B. Braun Medical Inc | 06/24/2010Terminated |
| Z-0305-2011 | B. Braun addEASE Binary Connector, Catalogue #N7990, 200 units (50 units per bag with 4…During this insertion, fragmentation of the PAB container stopper may occur resulting in a small amount of… | B. Braun Medical Inc | 06/24/2010Terminated |
| Z-1197-2010 | Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF: 724, STERILE, 10 per box. Baxa…Molding defect in the valve body causes leaking. | Baxa Corporation | 02/10/2010Terminated |
| Z-1420-2012 | Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three…Spike port flor EVA TPN Bags contains low levels of DEHP which could leach out. | Baxa Corporation | 05/08/2009Terminated |
| Z-1244-2009 | TEVADAPTOR Closed Drug Reconstitution and Transfer System, a closed system used to…Syringe adaptor is disintegrating when attached to the end of the syringe. | Migada Inc. | 12/18/2008Terminated |
| Z-1640-2008 | Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE)…Software anomaly results in inaccurate information being printed out on the Delivery Report, even though the… | Baxter Healthcare Corp. | 03/28/2008Terminated |
| Z-1549-2008 | Medex MX821L 72 inch (182.9cm) Administration Sets, Standard Drip, Sterile Single Use…Misbranded/mispackaged device was distributed. Product labeled to contain 72 inch Standard Drip ( IV)… | Smiths Medical Asd Inc | 03/24/2008Terminated |