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Baxter Healthcare Recalls
556 recalls on record · June 20, 2012 to August 19, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 15, 2015DrugsFDA
Baxter Healthcare Corp. recalls 10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station
Hazard: Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
July 15, 2015DrugsFDA
Baxter Healthcare Corp. recalls 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station R
Hazard: Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
July 15, 2015DrugsFDA
Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pit
Hazard: Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
June 17, 2015DrugsFDA
Baxter Healthcare Corp recalls Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only,
Hazard: Subpotent Drug; out of specification results for heparin raw material
May 6, 2015Medical DevicesFDA
Baxter Healthcare Corp. recalls The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of
Hazard: Potential for device malfunction resulting in flow when the device should not be flowing
April 22, 2015Medical DevicesFDA
Baxter Healthcare Corp recalls Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump)
Hazard: Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the nearest integer in minutes on the pump dose setup screen (20 sec may show as 1 min on the pump display). The pump will administer drugs as configured. The discrepancy may cause therapy delay or unintended rate of delivery.
April 15, 2015DrugsFDA
Baxter Healthcare Corp recalls 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, I
Hazard: Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
April 8, 2015DrugsFDA
Baxter Healthcare Corp recalls 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation
Hazard: Lack of Assurance of Sterility; increased complaints received for leaks
April 8, 2015DrugsFDA
Baxter Healthcare Corp recalls Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual C
Hazard: Lack of Assurance of Sterility; increased complaints received for leaks
April 1, 2015DrugsFDA
Baxter Healthcare Corp. recalls 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North
Hazard: Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
April 1, 2015DrugsFDA
Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Cor
Hazard: Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
March 25, 2015Medical DevicesFDA
Baxter Healthcare Corp. recalls The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Personal Cycler peritonea
Hazard: The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects the occluder blade to the manifold causing an unrecoverable system error, and/or 2) blade may separate from the back plate and cause Slow / No Flow alarm requiring therapy termination.
March 25, 2015Medical DevicesFDA
Baxter Healthcare Corp. recalls MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
Hazard: Product may have separating or protruding sponges
March 11, 2015Medical DevicesFDA
Baxter Healthcare Corp. recalls AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
Hazard: Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. The patients include neonates, infants, small children, and any patient with significant heart and/or lung disease.
February 11, 2015Medical DevicesFDA
Baxter Healthcare Corp. recalls Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device
Hazard: Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.
February 4, 2015Medical DevicesFDA
Baxter Healthcare Corp. recalls HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R
Hazard: The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
February 4, 2015Medical DevicesFDA
Baxter Healthcare Corp. recalls Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.
Hazard: Potential for failure of the pouch packaging seal at high altitudes.
February 4, 2015DrugsFDA
Baxter Healthcare Corp. recalls Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL
Hazard: Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
January 14, 2015Medical DevicesFDA
Baxter Healthcare Corp. recalls HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD syst
Hazard: There are additional and updated warning and cautions that are not in the Patient At-Home Guide for HomeChoice Automated PD Systems and HomeChoice PRO Automated PD Systems.
January 14, 2015Medical DevicesFDA
Baxter Healthcare Corp. recalls Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritone
Hazard: System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.
December 24, 2014DrugsFDA
Baxter Healthcare Corp. recalls Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY
Hazard: Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
December 17, 2014DrugsFDA
Baxter Healthcare Corp. recalls Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic,
Hazard: Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
December 3, 2014DrugsFDA
Baxter Healthcare Corp. recalls Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, M
Hazard: Subpotent Drug: Heparin raw material was found to have low potency
December 3, 2014DrugsFDA
Baxter Healthcare Corp. recalls Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-
Hazard: Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
November 12, 2014Medical DevicesFDA
Baxter Healthcare Corp recalls Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products
Hazard: Particulate matter found inside the fluid path.
November 12, 2014Medical DevicesFDA
Baxter Healthcare Corp recalls Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories.
Hazard: Particulate matter found inside the fluid path.
October 22, 2014Medical DevicesFDA
Baxter Healthcare Corp recalls 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
Hazard: The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage.
October 8, 2014Medical DevicesFDA
Baxter Healthcare Corp. recalls SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
Hazard: One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014.
October 8, 2014DrugsFDA
Baxter Healthcare Corp. recalls Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx
Hazard: Presence of Particulate Matter: particulate matter was found during the manufacturing process.
October 8, 2014DrugsFDA
Baxter Healthcare Corp. recalls DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.
Hazard: Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.