Baxter Healthcare Corp. Recalls — U.S. Recall Records

Recall history in this database

Classification mix: Class II: 93, Class I: 28, Class III: 3.

Medical DeviceJan 14, 2015

Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients recall — FDA Z-0932-2015

System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.

Class IIFDA: TerminatedBaxter Healthcare Corp.

DrugDec 24, 2014

Clinimix E 4.25/10 sulfite-free recall — FDA D-0301-2015

Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal

Class IIFDA: TerminatedBaxter Healthcare Corp.

DrugDec 17, 2014

Famotidine Injection 20 mg recall — FDA D-0293-2015

Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection…

Class IIFDA: TerminatedBaxter Healthcare Corp.

DrugDec 3, 2014

Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags recall — FDA D-0256-2015

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.

Class IIFDA: TerminatedBaxter Healthcare Corp.

DrugDec 3, 2014

Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a recall — FDA D-0276-2015

Subpotent Drug: Heparin raw material was found to have low potency

Class IIFDA: TerminatedBaxter Healthcare Corp.

Medical DeviceNov 12, 2014

Baxter 2B8013 Empty INTRA VIA Container with PVC Ports recall — FDA Z-0085-2015

Particulate matter found inside the fluid path.

Class IFDA: TerminatedBaxter Healthcare Corp

Medical DeviceNov 12, 2014

Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml recall — FDA Z-0084-2015

Particulate matter found inside the fluid path.

Class IFDA: TerminatedBaxter Healthcare Corp

Medical DeviceOct 22, 2014

Baxter Healthcare 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing recall — FDA Z-0080-2015

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.

Class IIFDA: TerminatedBaxter Healthcare Corp

DrugOct 8, 2014

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL recall — FDA D-1610-2014

Presence of Particulate Matter: particulate matter was found during the manufacturing process.

Class IFDA: TerminatedBaxter Healthcare Corp.

DrugOct 8, 2014

DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL recall — FDA D-0004-2015

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.

Class IIFDA: TerminatedBaxter Healthcare Corp.

Medical DeviceOct 8, 2014

Baxter Healthcare SPECTRUM Pump, Model No. 35700BAX recall — FDA Z-2738-2014

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.

Class IIFDA: TerminatedBaxter Healthcare Corp.

DrugOct 1, 2014

Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL recall — FDA D-1606-2014

Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.

Class IIFDA: TerminatedBaxter Healthcare Corp

DrugSep 24, 2014

SODIUM CHLORIDE 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX recall — FDA D-1592-2014

Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.

Class IFDA: TerminatedBaxter Healthcare Corp.

DrugSep 24, 2014

Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag recall — FDA D-1593-2014

Presence of Particulate Matter: particulate matter identified as fibers and/or plastics

Class IFDA: TerminatedBaxter Healthcare Corp.

DrugSep 24, 2014

SODIUM CHLORIDE 0.9% Sodium Chloride Injection USP recall — FDA D-1591-2014

Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.

Class IFDA: TerminatedBaxter Healthcare Corp.

Medical DeviceSep 17, 2014

Baxter Healthcare BaxterBuretrol Solution Set105" (2.7 m)150 mL Burette***Drip recall — FDA Z-2613-2014

Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the…

Class IIFDA: TerminatedBaxter Healthcare Corp

Medical DeviceSep 17, 2014

Baxter Healthcare BaxterNon-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL recall — FDA Z-2615-2014

Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the…

Class IIFDA: TerminatedBaxter Healthcare Corp

Medical DeviceSep 17, 2014

Baxter Healthcare BaxterBURETROL Solution Set105" (2.7 m) 150 mL BuretteDrip recall — FDA Z-2614-2014

Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the…

Class IIFDA: TerminatedBaxter Healthcare Corp

DrugAug 27, 2014

ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag recall — FDA D-1542-2014

Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing…

Class IIFDA: TerminatedBaxter Healthcare Corp

DrugJul 9, 2014

Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL recall — FDA D-1413-2014

Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.

Class IIFDA: TerminatedBaxter Healthcare Corp.

Medical DeviceJul 9, 2014

Baxter Healthcare EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and recall — FDA Z-1963-2014

If the universal ingredient (UI) in an active configuration is changed using the Configuration Editor, a flush of the outlet pump tube will not be initiated by the software. It could result…

Class IIFDA: TerminatedBaxter Healthcare Corp.

Medical DeviceJul 9, 2014

Baxter Healthcare Baxter, MiniCap with Povidone-Iodine solution, 5C4466P recall — FDA Z-1945-2014

the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall…

Class IIFDA: TerminatedBaxter Healthcare Corp.

DrugMay 7, 2014

Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container recall — FDA D-1276-2014

Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.

Class IFDA: TerminatedBaxter Healthcare Corp.

Medical DeviceApr 30, 2014

Baxter Healthcare SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product recall — FDA Z-1484-2014

Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences.

Class IFDA: TerminatedBaxter Healthcare Corp.

Understanding this recall history

This page summarizes recall records in which the official source identifies Baxter Healthcare Corp. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.