Container, I.V.
FDA product code KPE · Class II (moderate risk) · 21 CFR 880.5025 · General Hospital
117510(k) clearances
0PMA approvals
60recalls
Manufacturers
- Baxter Healthcare Corp 8
- Abbott Laboratories 6
- Baxa Corp., Sub. of Cook Group, Inc. 5
- Gil-Med Industries C/O Kegan & Kegan, Ltd. 4
- Williams Medical Co. 4
- Medi-Plast Intl., Inc. 4
- Advance Medical Designs, Inc. 3
- Medical & Pharmaceutical Supplies, Inc. 3
- The Healthcare Group Laboratories, Inc. 3
- Epic Medical Pte. , Ltd. 3
- Chartermed, Inc. 3
- B. Braun Medical, Inc. 2
- The Metrix Company 2
- Laboratorios Grifols, S.A. 2
- Kells Medical, Inc. 2
- Incutech, Inc. 2
- Healthtek, Inc. 2
- Haemotronic S.P.A. 2
- American Mcgaw 2
- Valmed S.R.L. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252079 | Disposable Infusion Bag for Parenteral NutritionKPE · Traditional | Beijing L&Z Medical Technology Development Co.… | 04/02/2026SE |
| K251980 | ClaveQS BagKPE · Traditional | Icu Medical, Inc. | 03/20/2026SE |
| K251139 | KabiHelp® Uno; KabiHelp® Advance plusKPE · Traditional | Fresenius Kabi AG | 01/09/2026SE |
| K252094 | eZSURE Empty Fluid ContainerKPE · Special | Epic Medical Pte. , Ltd. | 08/01/2025SE |
| K250459 | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml…KPE · Traditional | Technoflex Sas. | 04/18/2025SE |
| K241442 | eZSURE Empty Fluid Container with ProSeal Injection SiteKPE · Special | Epic Medical Pte. , Ltd. | 06/21/2024SE |
| K223674 | eZSURE Empty Fluid Container (models 426030, 426040, 426110)KPE · Traditional | Epic Medical Pte. , Ltd. | 09/01/2023SE |
| K222622 | Disposable Infusion Bag for Parenteral NutritionKPE · Traditional | Beijing L&Z Medical Technology Development Co.… | 02/16/2023SE |
| K210749 | Empty EVA BagKPE · Traditional | Haemotronic S.P.A. | 08/19/2021SE |
| K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLKPE · Traditional | Gilero, LLC | 05/06/2021SE |
| K193528 | Empty EVA BagKPE · Traditional | Haemotronic S.P.A. | 07/22/2020SE |
| K190328 | HCT Empty EVA Container PackKPE · Traditional | Health Care Technologies | 08/15/2019SE |
| K190305 | Additive CapKPE · Traditional | International Medical Industries, Inc. | 04/30/2019SE |
| K181393 | Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP…KPE · Traditional | Valmed S.R.L. | 02/15/2019SE |
| K132276 | Sterile Empty Glass Container, 250ML, Sterile Empty Glass Container, 500 ML, Sterile…KPE · Traditional | Hospira, Inc. | 11/12/2013SE |
| K121161 | Empty Eva Solution Container Empty Eva Dual Chamber Solution ContainerKPE · Traditional | Acta Medical, LLC | 07/13/2012SE |
| K111217 | Additive CapKPE · Traditional | Baxter Healthcare Corp | 06/14/2011SE |
| K101412 | Eva TPN BagKPE · Traditional | Valmed S.R.L. | 04/13/2011SE |
| K090096 | All-In-One ContainerKPE · Traditional | Baxter Healthcare Corporation | 01/30/2009SE |
| K073538 | Dual Chamber TPN ContainerKPE · Traditional | B.Braun Medical, Inc. | 03/12/2008SE |
| K061197 | Kawasumi Laboratories Empty Solution ContainerKPE · Traditional | Kawasumi Laboratories, Inc. | 06/30/2006SE |
| K041038 | Churchill Medical Dual Chamber Empty ContainerKPE · Abbreviated | Churchill Medical Systems, Inc. | 12/21/2004SE |
| K041415 | Eva TPN ContainerKPE · Traditional | B.Braun Medical, Inc. | 08/04/2004SE |
| K033916 | Gri-Bag, Gri-Bag ApKPE · Traditional | Laboratorios Grifols, S.A. | 12/30/2003SE |
| K031419 | Gri-Flex, Models 1000ML, 500ML, 250ML, 100MLKPE · Traditional | Laboratorios Grifols, S.A. | 11/24/2003SE |
| K030888 | Eva Empty Solution ContainerKPE · Special | Metrix Co. | 04/02/2003SE |
| K020485 | All-In-One Two Chamber Container 3200 ML, 2000 ML & 1000 MLKPE · Special | Baxter Healthcare Corp | 03/12/2002SE |
| K001461 | TPN Nutrition Bag (Eva), Emptying Tube, Bag Syringe Fill SetKPE · Traditional | Biometrix , Ltd. | 09/11/2000SE |
| K001287 | Empty Reservoir Bag, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 MLKPE · Traditional | Sorenson Medical, Inc. | 06/09/2000SE |
| K983294 | All-In-One Container Cat#'s 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112…KPE · Traditional | Baxter Healthcare Corp | 11/03/1998SE |
| K982048 | MPS Reservoir BagKPE · Traditional | Medical Product Specialists | 07/27/1998SE |
| K974180 | Steri-TampKPE · Traditional | Pharmacy, Inc. | 02/24/1998SE |
| K973103 | Chartermed Tpn-Eva BagsKPE · Traditional | Chartermed, Inc. | 11/24/1997SE |
| K972464 | Vitalmix Plus Empty I.V. ContainerKPE · Traditional | Pacific Device, Inc. | 11/05/1997SE |
| K964853 | Intravia Container, EmptyKPE · Traditional | Baxter Healthcare Corp | 03/31/1997SE |
| K960581 | Secure Eva Dual Chamber Mixing BagKPE · Traditional | Secure Medical Products, Inc. | 04/30/1996SE |
| K945193 | All-In-One Two Chamber ContainerKPE · Traditional | Baxter Healthcare Corp | 05/12/1995SE |
| K941731 | Empty, Solution Transfer Container with Detatchable Leg SetKPE · Traditional | Incutech, Inc. | 07/22/1994SE |
| K932477 | Unimix Conainer-Empty Container W/3 Lead Trans.SetKPE · Traditional | Baxter Healthcare Corp | 06/10/1994SE |
| K934179 | Disposable Bag DecanterKPE · Traditional | Byron Medical | 05/23/1994SE |
| K940258 | Solution Transfer Container W/Attached Leg Set (Empty)KPE · Traditional | Incutech, Inc. | 03/28/1994SE |
| K932649 | PharmafeedKPE · Traditional | Plasco, Inc. | 11/16/1993SE |
| K932641 | Empty Mixing ContainerKPE · Traditional | Douglas Medical Products Corp. | 11/10/1993SE |
| K932640 | Eva Empty Mixing ContainerKPE · Traditional | Douglas Medical Products Corp. | 11/10/1993SE |
| K926123 | Dual Chamber Mixing BagKPE · Traditional | Secure Medical, Inc. | 09/03/1993SE |
| K923448 | Empty Solution Transfer Container W/ Detach LegKPE · Traditional | Healthtek, Inc. | 07/28/1993SE |
| K922214 | Empty Viaflex Plastic ContainerKPE · Traditional | Baxter Healthcare Corp | 03/26/1993SE |
| K913608 | SnapperKPE · Traditional | Healthtek, Inc. | 11/29/1991SE |
| K911567 | Dual Compartment TPN Bag 3 LiterKPE · Traditional | Stedim, Inc. | 08/02/1991SE |
| K910936 | Empty I.V. ContainerKPE · Traditional | Ellis Pharmaceutical Consulting, Inc. | 07/16/1991SE |
| K911576 | Chemotherapy ContainerKPE · Traditional | Bemis Mfg. Co. | 07/05/1991SE |
| K910673 | Bag SpigotKPE · Traditional | Procedure Products, Inc. | 04/24/1991SE |
| K902079 | Admixture Container for Total Parenteral NutritionKPE · Traditional | Chartermed, Inc. | 10/29/1990SE |
| K902464 | Chartermed Empty TPN Container - 100 ML CapacityKPE · Traditional | Chartermed, Inc. | 08/30/1990SE |
| K895924 | Metricare Drug ReservoirsKPE · Traditional | Metrix Co. | 07/26/1990SE |
| K883400 | Optum(Tm) Automated Patient Assist DeviceKPE · Traditional | Abbott Laboratories | 12/01/1989SE |
| K885173 | Mix Container W/Attached Transfer SetKPE · Traditional | Medical Support Systems | 06/07/1989SE |
| K891077 | Mediverse Parenteral Nutrition BagKPE · Traditional | Mediflex Intl. | 05/24/1989SE |
| K890095 | PVC Empty Solution Container W/3 Lead Transfer SetKPE · Traditional | Kells Medical, Inc. | 05/24/1989SE |
| K890094 | Eva Empty Solution Container W/3 Lead Transfer SetKPE · Traditional | Kells Medical, Inc. | 05/24/1989SE |
| K890268 | Pressure Infusor for I.V. Bags/AutoinflationKPE · Traditional | Biomedical Dynamics, Inc. | 05/05/1989SE |
| K890272 | Bag DecanterKPE · Traditional | Superior Medical Products | 03/14/1989SE |
| K880506 | Modified Eva-Mix and Di-Mix BagsKPE · Traditional | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 05/20/1988SE |
| K875155 | 60 ML Reservoir Bag, Item #200KPE · Traditional | Prn Services, Inc. | 02/16/1988SE |
| K870395 | Churchill Parenteral Nutrition Bag - EvaKPE · Traditional | Churchill Corp. | 10/15/1987SE |
| K871449 | Oncology SPT Sys #MS-C10 Medication Reservoir BagKPE · Traditional | Pa Medical Corp. | 06/17/1987SE |
| K870052 | Infumix Mixing ContainerKPE · Traditional | Biodynamics Corp. | 02/27/1987SE |
| K870113 | Thermal Jacket for I.V. Fluid BagsKPE · Traditional | Thermal Medical Systems, Inc. | 02/25/1987SE |
| K870274 | Di-Mix Parenteral Nutrition & Medicine ContainerKPE · Traditional | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 02/10/1987SE |
| K863040 | Disposable Intravenous Hyperalimentation BagsKPE · Traditional | Cher Mel Corp. | 10/31/1986SE |
| K860042 | Nutrimix Empty ContainerKPE · Traditional | Abbott Laboratories | 04/09/1986SE |
| K854034 | Snap-Lock Additive Cap #Sl 300KPE · Traditional | Williams Medical Co. | 11/06/1985SE |
| K854033 | Snap-Lock Additive Cap #SL400KPE · Traditional | Williams Medical Co. | 11/06/1985SE |
| K854031 | Snap-Lock Additive Cap #SL100KPE · Traditional | Williams Medical Co. | 11/06/1985SE |
| K854032 | Snap-Lock Additive Cap #Sl 200KPE · Traditional | Williams Medical Co. | 11/01/1985SE |
| K852938 | Tuf Track Model TT83 Cubicle Track & IV83 Intr TRKKPE · Traditional | Northern Customfab, Inc. | 09/30/1985SE |
| K852893 | Vial DecanterKPE · Traditional | Advance Medical Designs, Inc. | 09/20/1985SE |
| K852778 | Bottle DecanterKPE · Traditional | Advance Medical Designs, Inc. | 08/16/1985SE |
| K852777 | Bag DecanterKPE · Traditional | Advance Medical Designs, Inc. | 08/16/1985SE |
| K850035 | Empty Solution Transfer ContainerKPE · Traditional | The Healthcare Group Laboratories, Inc. | 06/07/1985SE |
| K844664 | The I.V. BagKPE · Traditional | Kabivitrum, Inc. | 05/06/1985SE |
| K844077 | Nutrimix Empty ContainerKPE · Traditional | Abbott Laboratories | 02/15/1985SE |
| K844410 | Nutribag Mixing Container -2000 MLKPE · Traditional | Medical & Pharmaceutical Supplies, Inc. | 11/28/1984SE |
| K843954 | Mixing ContainerKPE · Traditional | American Mcgaw | 11/28/1984SE |
| K841597 | Gil-Med Parenteral Nutrition or MedicineKPE · Traditional | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 10/26/1984SE |
| K842170 | Empty Solution Transfer ContainerKPE · Traditional | The Healthcare Group Laboratories, Inc. | 10/19/1984SE |
| K843523 | Empty Solution Transfer Container 1000KPE · Traditional | Polymer Technology Corp. | 10/16/1984SE |
| K842629 | Home Nutribag Mixing Container 3000MLKPE · Traditional | Medical & Pharmaceutical Supplies, Inc. | 09/07/1984SE |
| K842628 | Home Nutribag Mixing Container 1000MLKPE · Traditional | Medical & Pharmaceutical Supplies, Inc. | 09/07/1984SE |
| K840915 | Dimix Container for Parneteral NutritKPE · Traditional | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 04/17/1984SE |
| K840388 | Pab IV ContainerKPE · Traditional | American Mcgaw | 03/06/1984SE |
| K832254 | Baxa AddisealKPE · Traditional | Baxa Corp., Sub. of Cook Group, Inc. | 07/26/1983SE |
| K832247 | I.V. Bag AddisealKPE · Traditional | Baxa Corp., Sub. of Cook Group, Inc. | 07/26/1983SE |
| K830193 | Cat 3040KPE · Traditional | Burron Medical Products, Inc. | 03/09/1983SE |
| K830450 | Delmed IV ContainerKPE · Traditional | Delmed, Inc. | 03/01/1983SE |
| K830299 | Solution Transfer ContainerKPE · Traditional | The Healthcare Group Laboratories, Inc. | 02/19/1983SE |
| K830232 | Decanter Models-VariousKPE · Traditional | Steri-Sytems, Corp. | 02/09/1983SE |
| K823538 | Pour Bottle Decanter #2010KPE · Traditional | Medi-Plant Intl. | 01/26/1983SE |
| K820200 | IV Alert SystemKPE · Traditional | Allied Medical Technologies, Inc. | 03/18/1982SE |
| K820435 | Baxa AddisealKPE · Traditional | Baxa Corp., Sub. of Cook Group, Inc. | 03/08/1982SE |
| K813435 | Baxa Adli SealKPE · Traditional | Baxa Corp., Sub. of Cook Group, Inc. | 12/18/1981SE |
| K812852 | Set for Aseptic Decanting of a Flex I.VKPE · Traditional | Dip, Inc. | 11/02/1981SE |
| K812527 | Iva Seal IIKPE · Traditional | U.S. Clinical Products, Inc. | 09/16/1981SE |
| K811268 | Bottle-To-BottleKPE · Traditional | Medi-Plast Intl., Inc. | 06/18/1981SE |
| K811234 | I.V. Bottle (Ridgid)KPE · Traditional | Medi-Plast Intl., Inc. | 06/18/1981SE |
| K811233 | I.V. Plastic BagKPE · Traditional | Medi-Plast Intl., Inc. | 06/17/1981SE |
| K811269 | Glass VialsKPE · Traditional | Medi-Plast Intl., Inc. | 06/16/1981SE |
| K810795 | InstafilKPE · Traditional | Instafil, Inc. | 06/12/1981SE |
| K802966 | I.V. Additive CapKPE · Traditional | Baxa Corp., Sub. of Cook Group, Inc. | 01/07/1981SE |
| K801652 | Total Parenteral Nutrition Set BagKPE · Traditional | Cutter Laboratories, Inc. | 08/27/1980SE |
| K791774 | Life Care 1000ML.EMP. Cont. W/At. Y-TranKPE · Traditional | Abbott Laboratories | 10/26/1979SE |
| K791796 | Additive Hinge CapKPE · Traditional | Abbott Laboratories | 10/01/1979SE |
| K782113 | Cap, Tamper Proof PlasticKPE · Traditional | Acacia, Inc. | 06/01/1979SE |
| K771432 | Hicaliq Ivh BagKPE · Traditional | Terumo America, Inc. | 09/28/1977SE |
| K771121 | Empty Admixture ContainersKPE · Traditional | Medi, Inc. | 08/03/1977SE |
| K771228 | Lifecare Empty ContainerKPE · Traditional | Abbott Laboratories | 08/02/1977SE |
| K760880 | Additive Cap (2B8905)KPE · Traditional | Travenol Laboratories, S.A. | 12/30/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0345-2025 Class II | Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | The Metrix Company | 10/09/2024Open, Classified |
| Z-0344-2025 Class II | Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made…A limited number of IV bags have been found to leak during filling. | The Metrix Company | 10/09/2024Open, Classified |
| Z-0343-2025 Class II | Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made…A limited number of IV bags have been found to leak during filling. | The Metrix Company | 10/09/2024Open, Classified |
| Z-0342-2025 Class II | Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made…A limited number of IV bags have been found to leak during filling. | The Metrix Company | 10/09/2024Open, Classified |
| Z-0341-2025 Class II | SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | The Metrix Company | 10/09/2024Open, Classified |
| Z-0340-2025 Class II | SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | The Metrix Company | 10/09/2024Open, Classified |
| Z-0339-2025 Class II | SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | The Metrix Company | 10/09/2024Open, Classified |
| Z-0338-2025 Class II | SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty…A limited number of IV bags have been found to leak during filling. | The Metrix Company | 10/09/2024Open, Classified |
| Z-0337-2025 Class II | SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made…A limited number of IV bags have been found to leak during filling. | The Metrix Company | 10/09/2024Open, Classified |
| Z-0336-2025 Class II | SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty…A limited number of IV bags have been found to leak during filling. | The Metrix Company | 10/09/2024Open, Classified |
| Z-0335-2025 Class II | SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | The Metrix Company | 10/09/2024Open, Classified |
| Z-0334-2025 Class II | CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | The Metrix Company | 10/09/2024Open, Classified |
| Z-0333-2025 Class II | CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | The Metrix Company | 10/09/2024Open, Classified |
| Z-0332-2025 Class II | CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | The Metrix Company | 10/09/2024Open, Classified |
| Z-0331-2025 Class II | VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | The Metrix Company | 10/09/2024Open, Classified |
| Z-0330-2025 Class II | VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch…A limited number of IV bags have been found to leak during filling. | The Metrix Company | 10/09/2024Open, Classified |
| Z-2685-2024 Class II | Regard Kit containing the Microtek decanterDecanters may have pin holes and tears in sterile packaging that cannot be identified visually. | ROi CPS LLC | 06/17/2024Open, Classified |
| Z-2643-2024 Class II | Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek…During sterile barrier testing performed on the decanter product line, the samples were identified to have… | Microtek Medical Inc. | 06/03/2024Open, Classified |
| Z-2642-2024 Class II | Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek…During sterile barrier testing performed on the decanter product line, the samples were identified to have… | Microtek Medical Inc. | 06/03/2024Open, Classified |
| Z-2641-2024 Class II | Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek…During sterile barrier testing performed on the decanter product line, the samples were identified to have… | Microtek Medical Inc. | 06/03/2024Open, Classified |
| Z-2640-2024 Class II | Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek…During sterile barrier testing performed on the decanter product line, the samples were identified to have… | Microtek Medical Inc. | 06/03/2024Open, Classified |
| Z-2639-2024 Class II | C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a…During sterile barrier testing performed on the decanter product line, the samples were identified to have… | Microtek Medical Inc. | 06/03/2024Open, Classified |
| Z-0937-2023 Class II | HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | Stradis Healthcare | 12/15/2022Open, Classified |
| Z-0936-2023 Class II | HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE.…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | Stradis Healthcare | 12/15/2022Open, Classified |
| Z-1592-2022 Class II | B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-0008-2020 Class II | ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250…Potential for leaking product | The Metrix Company | 09/21/2018Open, Classified |
| Z-0007-2020 Class II | ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500…Potential for leaking product | The Metrix Company | 09/21/2018Open, Classified |
| Z-0006-2020 Class II | SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian…Potential for leaking product | The Metrix Company | 09/21/2018Open, Classified |
| Z-0005-2020 Class II | SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian…Potential for leaking product | The Metrix Company | 09/21/2018Open, Classified |
| Z-0004-2020 Class II | SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian…Potential for leaking product | The Metrix Company | 09/21/2018Open, Classified |
| Z-0003-2020 Class II | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 -…Potential for leaking product | The Metrix Company | 09/21/2018Open, Classified |
| Z-0002-2020 Class II | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 -…Potential for leaking product | The Metrix Company | 09/21/2018Open, Classified |
| Z-0001-2020 Class II | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 -…Potential for leaking product | The Metrix Company | 09/21/2018Open, Classified |
| Z-0367-2019 Class II | EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold…Potential ability to leak once used for compounding. | Baxter Healthcare Corporation | 09/12/2018Terminated |
| Z-0366-2019 Class II | EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold…Potential ability to leak once used for compounding. | Baxter Healthcare Corporation | 09/12/2018Terminated |
| Z-0365-2019 Class II | EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold…Potential ability to leak once used for compounding. | Baxter Healthcare Corporation | 09/12/2018Terminated |
| Z-0364-2019 Class II | EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold…Potential ability to leak once used for compounding. | Baxter Healthcare Corporation | 09/12/2018Terminated |
| Z-0363-2019 Class II | EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold…Potential ability to leak once used for compounding. | Baxter Healthcare Corporation | 09/12/2018Terminated |
| Z-3240-2017 Class II | SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE…The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are… | The Metrix Company | 09/13/2017Terminated |
| Z-0485-2018 Class II | Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use…A leak may allow for microbial contamination of the sterile fluid path. | Baxter Healthcare Corporation | 07/27/2017Terminated |
| Z-0085-2015 Class I | Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid…Particulate matter found inside the fluid path. | Baxter Healthcare Corp | 09/16/2014Terminated |
| Z-0084-2015 Class I | Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml…Particulate matter found inside the fluid path. | Baxter Healthcare Corp | 09/16/2014Terminated |
| 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. | Hospira Inc. | 08/28/2012Terminated |
| Z-2148-2010 | Exacta - Mix Valve Set, Six Inlet, Tubing Kit w/Calibration Bag, Fluid Path is sterile…Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | Baxa Corporation | 05/26/2010Terminated |
| Z-2147-2010 | Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled, Tubing Kit w/Calibration Bag…Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | Baxa Corporation | 05/26/2010Terminated |
| Z-2146-2010 | Exacta-Mix 2400 Valve Assembly w/Calibration Bag, Sterile R, 250 mL, Order No. REF: 724…Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | Baxa Corporation | 05/26/2010Terminated |
| Z-2145-2010 | Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL Reorder No. H938…Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | Baxa Corporation | 05/26/2010Terminated |
| Z-2144-2010 | Halobag EVA Dual-Chamber Bag, Sterile R, 3000 mL Total Volume W/500 mL upper chamber…Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | Baxa Corporation | 05/26/2010Terminated |
| Z-2143-2010 | Exacta-Mix EVA Container, Sterile R, 5000 mL, Order No. REF: 143, Baxa Corporation.Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | Baxa Corporation | 05/26/2010Terminated |
| Z-2142-2010 | Exacta-Mix EVA Container, Sterile R, 4000 mL, Order No. REF: 142, Baxa Corporation.Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid… | Baxa Corporation | 05/26/2010Terminated |