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.

26–50 of 144

  • HighFDA (Devices)·Z-0605-2016·2016-01-13

    Baxter Y-Type Spike Adapter Recalled for Potential Particulate Matter

    Baxter Healthcare is recalling Y-Type Spike Adapters due to the potential presence of dark loose particulate matter on the spike.

    Product
    Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a container into the patients vascular system through a vascular access device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0606-2016·2016-01-13

    Baxter INTERLINK Y-Type Solution Set Recalled for Particulate Matter

    Baxter Healthcare is recalling INTERLINK Y-Type Solution Sets due to potential dark particulate matter on the spike adapter.

    Product
    Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the administration of fluids from a container into the patients vascular system through a vascular access device. .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0607-2016·2016-01-13

    Baxter CLEARLINK Blood Bag Spike Adapter Recalled for Particulate Matter

    Baxter Healthcare is recalling CLEARLINK Blood Bag Spike Adapters due to potential dark loose particulate matter on the spike.

    Product
    Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a medicinal product from one container to another container.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0291-2016·2015-11-25

    Baxter HomeChoice APD Systems Recalled for Loud Operating Sounds

    Baxter is recalling HomeChoice and HomeChoice Pro APD systems due to loud operating sounds. The devices function correctly, but the noise is unacceptable to users.

    Product
    Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0194-2016·2015-11-11

    Baxter 15L Cycler Drainage Bags Recalled for Inlet Port Leakage

    Baxter Healthcare Corp. is recalling 19,440 units of 15L Cycler Drainage Bags due to leakage from the inlet port. The products were distributed in the US and Canada.

    Product
    Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0132-2016·2015-10-28

    Baxter Recalls Microbore Catheter Extension Sets Due to Potential Leak

    Baxter Healthcare Corp is recalling 23,600 units of One-Link Microbore Catheter Extension Sets due to a potential leak at the tubing to luer bond.

    Product
    ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2473-2015·2015-09-02

    Baxter MiniCap Extended Life PD Transfer Set Labeling Recall

    Baxter Healthcare Corp. is recalling 33,474 units of MiniCap Extended Life PD Transfer Sets to update labeling with additional safety instructions and warnings.

    Product
    MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2472-2015·2015-09-02

    Baxter MiniCap Peritoneal Dialysis Transfer Set Labeling Recall

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets to update labeling with safety instructions and warnings.

    Product
    MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are perf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2474-2015·2015-09-02

    Baxter Recalls CAPD Solution Transfer Sets for Labeling Revisions

    Baxter Healthcare Corp. is recalling 35,460 units of CAPD Solution Transfer Sets to update labeling with additional safety instructions and warnings.

    Product
    CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL peritoneal dialysis solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2471-2015·2015-09-02

    Baxter Recalls MiniCap Peritoneal Dialysis Transfer Sets for Labeling Updates

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets to update labeling with new safety instructions and warnings.

    Product
    MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnect
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1210-2015·2015-07-15

    Baxter Recalls 10% Dextrose Injection Bags Due to Metal Particulate Matter

    Baxter Healthcare is recalling 18,324 bags of 10% Dextrose Injection due to the presence of metal particulate matter. The affected products were distributed in the US, Puerto Rico, and Bermuda.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1211-2015·2015-07-15

    Baxter Recalls Lactated Ringers Bags Due to Metal Particulate Matter

    Baxter Healthcare is recalling specific lots of Lactated Ringers Injection due to the presence of metal particulate matter.

    Product
    LACTATED RINGERS — LACTATED RINGERS (SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1131-2015·2015-06-17

    Baxter Recalls Subpotent Heparin Sodium Injection Due to Raw Material Issues

    Baxter Healthcare is recalling specific lots of Heparin Sodium in Sodium Chloride Injection because the raw material was found to be subpotent and out of specification.

    Product
    HEPARIN SODIUM IN SODIUM CHLORIDE — HEPARIN SODIUM IN SODIUM CHLORIDE (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1536-2015·2015-05-06

    Baxter Patient Control Modules Recalled for Potential Malfunction

    Baxter Healthcare is recalling 7,596 Patient Control Modules due to a potential malfunction that could cause medication to flow when it should not.

    Product
    The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1451-2015·2015-04-22

    Baxter SIGMA Spectrum Infusion Pump Software Recall for Dose Display Discrepancy

    Baxter is recalling SIGMA Spectrum Infusion Pump software due to a discrepancy between Master Drug Library settings and pump display, which may cause therapy delays or unintended delivery rates.

    Product
    Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administratio
    Category
    Medical Device
    Distribution
    21 states
  • SevereFDA (Drugs)·D-481-2015·2015-04-15

    Baxter Recalls Sodium Chloride Injection Bags Due to Plastic Fragments

    Baxter Healthcare is recalling 542,080 bags of 0.9% Sodium Chloride Injection USP due to confirmed reports of blue plastic fragments from vial adapters.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0428-2015·2015-04-08

    Baxter Recalls Clinimix E Due to Sterility Assurance Concerns

    Baxter Healthcare is recalling 7,444 containers of Clinimix E 5/20 due to a lack of assurance of sterility and increased leak complaints.

    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-0426-2015·2015-04-01

    Baxter Recalls 5% Dextrose Injection Due to Sterility Concerns

    Baxter Healthcare is recalling 48,874 units of 5% Dextrose Injection because missing closures or leaks may compromise sterility.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    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.