The Recall Desk

Manufacturer

Baxter Healthcare Corp.

144 recalls in our database name Baxter Healthcare Corp. as the manufacturing or recalling firm.

What the numbers show

Total
144
Critical
18
Severe
30
Most recent
2017-09-20

Of the 144 recalls from Baxter Healthcare Corp. we have scored against our rubric, 18 (13%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 30 (21%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 144

  • SevereFDA (Drugs)·D-0425-2015·2015-04-01

    Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns

    Baxter Healthcare is recalling 0.9% Sodium Chloride Injection due to reports of missing closures and leaks that may compromise sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1269-2015·2015-03-25

    Baxter MiniCap with Povidone-Iodine Solution Recalled for Sponge Defects

    Baxter Healthcare is recalling MiniCap with Povidone-Iodine Solution units for hemodialysis because the product may have separating or protruding sponges.

    Product
    MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1292-2015·2015-03-25

    Baxter HomeChoice Pro APD System Recalled for Occluder Defect

    Baxter Healthcare is recalling 75 HomeChoice Pro APD systems because the occluder may have sharp edges or separate, causing system errors or therapy termination.

    Product
    The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing per
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1245-2015·2015-03-11

    Baxter AMIA v1.0 APD System Recall for Labeling Warning

    Baxter Healthcare is recalling 55 AMIA v1.0 APD Systems to add a warning about the risk of unintended increased intraperitoneal volume for vulnerable patients.

    Product
    AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1039-2015·2015-02-11

    Baxter Integrated APD Set Recalled for Leakage Complaints

    Baxter Healthcare is recalling 8,640 units of Integrated APD Sets with Cassette 3-Prong due to leakage complaints. The sterile fluid path is used for peritoneal dialysis.

    Product
    Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1031-2015·2015-02-04

    Baxter HomeChoice Peritoneal Dialysis Cycler Recalled for Keypad Malfunction

    Baxter Healthcare is recalling HomeChoice and HomeChoice Pro automated peritoneal dialysis cyclers because the keypad buttons may activate without being pressed.

    Product
    HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Drugs)·D-0380-2015·2015-02-04

    Baxter Recalls Fluconazole Injection Bags Due to Seal Defects

    Baxter Healthcare is recalling 31,130 bags of Fluconazole Injection due to potential leaks from incomplete seals, which may compromise sterility.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1010-2015·2015-02-04

    Baxter Recalls Four Lead TUR Irrigation Sets Due to Seal Failure Risk

    Baxter Healthcare is recalling 26,028 units of Four Lead TUR Irrigation Sets because the pouch packaging seal may fail at high altitudes.

    Product
    Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0939-2015·2015-01-14

    Baxter HomeChoice Automated Peritoneal Dialysis Systems Recalled for Updated Warnings

    Baxter Healthcare is recalling HomeChoice and HomeChoice Pro Automated Peritoneal Dialysis systems because the patient guide lacks updated warnings and cautions.

    Product
    HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0932-2015·2015-01-14

    Baxter Amia Automated PD Systems Recalled for Battery Charging Error

    Baxter Healthcare is recalling 55 Amia Automated PD systems due to a battery charging error that prevents the device from functioning.

    Product
    Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0301-2015·2014-12-24

    Baxter Recalls Clinimix E IV Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 7,220 bags of Clinimix E IV solution because leaks were observed, raising concerns about sterility.

    Product
    CLINIMIX E — CLINIMIX E (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0276-2015·2014-12-03

    Baxter Recalls Heparin Sodium Injection Due to Low Potency

    Baxter Healthcare is recalling Heparin Sodium in Sodium Chloride Injection because the raw material was found to have low potency.

    Product
    HEPARIN SODIUM IN SODIUM CHLORIDE — HEPARIN SODIUM IN SODIUM CHLORIDE (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0256-2015·2014-12-03

    Baxter Recalls Potassium Chloride Injection Bags Due to Labeling Error

    Baxter Healthcare is recalling 63,360 bags of Potassium Chloride Injection due to incorrect outer packaging labels indicating a higher strength.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0085-2015·2014-11-12

    Baxter INTRA VIA Container Recalled for Particulate Matter in Fluid Path

    Baxter Healthcare is recalling 20,448 units of INTRA VIA containers due to particulate matter found inside the fluid path.

    Product
    Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0084-2015·2014-11-12

    Baxter INTRA VIA Container Recalled for Particulate Matter in Fluid Path

    Baxter Healthcare Corp is recalling 94,224 INTRA VIA containers due to particulate matter found inside the fluid path.

    Product
    Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0080-2015·2014-10-22

    Baxter 15 L Cycler Drainage Bag Recalled for Potential Drain Tube Leakage

    Baxter Healthcare is recalling 15 L Cycler Drainage Bags because the tube clamp may not fully close, potentially causing leakage.

    Product
    15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1610-2014·2014-10-08

    Baxter Recalls Dianeal Low Calcium Peritoneal Dialysis Solution Bags

    Baxter Healthcare is recalling 50,530 bags of Dianeal Low Calcium peritoneal dialysis solution due to the presence of particulate matter found during manufacturing.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0004-2015·2014-10-08

    Baxter Recalls Dopamine Hydrochloride Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 11,808 bags of Dopamine Hydrochloride and Dextrose due to a potential manufacturing defect that may compromise sterility.

    Product
    DOPAMINE HYDROCHLORIDE AND DEXTROSE — DOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2738-2014·2014-10-08

    Baxter SPECTRUM Pump Recall Due to Service Technician Error

    Baxter Healthcare is recalling SPECTRUM Pumps because a service technician may not have followed established procedures between May 5 and June 3, 2014.

    Product
    SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1606-2014·2014-10-01

    Baxter Recalls Potassium Chloride Bags Due to Mispackaging Error

    Baxter Healthcare is recalling 148,632 bags of Potassium Chloride Injection because shipping cartons were incorrectly labeled and contained Gentamicin Sulfate Injection instead.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1591-2014·2014-09-24

    Baxter Recalls Sodium Chloride Injection Bags Due to Particulate Matter

    Baxter Healthcare is recalling specific lots of 0.9% Sodium Chloride Injection USP bags due to the presence of particulate matter, including fibers and plastics.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1592-2014·2014-09-24

    Baxter Recalls Sodium Chloride Injection Bags Due to Particulate Matter

    Baxter Healthcare is recalling 390,560 bags of 0.9% Sodium Chloride Injection USP due to the presence of particulate matter, including fibers and plastics.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1593-2014·2014-09-24

    Baxter Recalls Potassium Chloride Injection Due to Particulate Matter

    Baxter Healthcare is recalling 171,672 bags of Potassium Chloride Injection due to the presence of particulate matter, including fibers and plastics.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1583-2014·2014-09-17

    Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns

    Baxter Healthcare is recalling 157,080 containers of 0.9% Sodium Chloride Injection due to complaints of mold in the overpouch, raising concerns about sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Baxter Healthcare Corporation

business enterprise in United States of America

Country
United States

Source: Wikidata (Q45134864), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.