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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.
October 1, 2014DrugsFDA
Baxter Healthcare Corp recalls Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container b
Hazard: Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.
September 24, 2014DrugsFDA
Baxter Healthcare Corp. recalls Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corp
Hazard: Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
September 24, 2014DrugsFDA
Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter H
Hazard: Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
September 24, 2014DrugsFDA
Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306;
Hazard: Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
September 17, 2014Medical DevicesFDA
Baxter Healthcare Corp recalls ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve 3 Luer Activated
Hazard: 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 drip chamber. Affected product codes are: 2C7564, 2C8864 and 2H8864.
September 17, 2014Medical DevicesFDA
Baxter Healthcare Corp recalls ***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamber Filter Valve***3 Luer Activated Valves**
Hazard: 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 drip chamber. Affected product codes are: 2C7564, 2C8864 and 2H8864.
September 17, 2014Medical DevicesFDA
Baxter Healthcare Corp recalls ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male
Hazard: 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 drip chamber. Affected product codes are: 2C7564, 2C8864 and 2H8864.
September 17, 2014DrugsFDA
Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC
Hazard: Lack of Assurance of Sterility; complaints of mold in the overpouch
August 27, 2014DrugsFDA
Baxter Healthcare Corp. recalls 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL
Hazard: Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes
August 27, 2014DrugsFDA
Baxter Healthcare Corp recalls ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation
Hazard: 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 iron, silicone and chlorine).
August 6, 2014Medical DevicesFDA
Baxter Healthcare Corporation recalls FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis o
Hazard: Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resulting in a loss of Doppler signal. This may result in the inability to monitor anastomotic patency, with the possibility that blood flow may not be appropriately monitored.
July 23, 2014Medical DevicesFDA
Baxter Healthcare Corp. recalls Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
Hazard: Inadequate iodine and packaging related defects.
July 9, 2014Medical DevicesFDA
Baxter Healthcare Corp. recalls EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200
Hazard: 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 in the original UI remaining in the tube which could be delivered into the next bag.
July 9, 2014Medical DevicesFDA
Baxter Healthcare Corp. recalls Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.
Hazard: 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 packaging.
July 9, 2014DrugsFDA
Baxter Healthcare Corp. recalls Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use In
Hazard: Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
May 7, 2014DrugsFDA
Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfie
Hazard: Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
May 7, 2014DrugsFDA
Baxter Healthcare Corp. recalls Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare
Hazard: Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
April 30, 2014Medical DevicesFDA
Baxter Healthcare Corp. recalls SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion P
Hazard: 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.
March 26, 2014DrugsFDA
Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, N
Hazard: Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
March 26, 2014DrugsFDA
Baxter Healthcare Corp. recalls 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerf
Hazard: Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
March 26, 2014DrugsFDA
Baxter Healthcare Corp. recalls Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx onl
Hazard: Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
March 26, 2014DrugsFDA
Baxter Healthcare Corp. recalls Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLA
Hazard: Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
March 26, 2014DrugsFDA
Baxter Healthcare Corp. recalls Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, R
Hazard: Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
February 12, 2014DrugsFDA
Baxter Healthcare Corp. recalls 50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield,
Hazard: Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
January 8, 2014Medical DevicesFDA
Baxter Healthcare Corp. recalls IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing in
Hazard: Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the IntelliFill i.v. Pharmacy Compounding Device (PCD) (product code: IFIV) has the potential to continue to run and fill syringes with the HEPA filtration disabled.
December 25, 2013DrugsFDA
Baxter Healthcare Corp. recalls 10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter Healthcare Corporat
Hazard: Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
December 4, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VI
Hazard: Incomplete foil seal on one lot of sterile product.
November 20, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intra
Hazard: Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.
November 20, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage:
Hazard: Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion Pump with Master Drug Library for not meeting standards for withstanding an electrostatic discharge.
November 13, 2013Medical DevicesFDA
Baxter Healthcare Corp. recalls Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as m
Hazard: The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events.