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.

126–144 of 144

  • HighFDA (Devices)·Z-1268-2013·2013-05-15

    Baxter Recalls Non-DEHP Catheter Extension Sets Due to Sterile Barrier Compromise

    Baxter Healthcare is recalling specific lots of Non-DEHP catheter extension sets because separating packages can compromise the sterile barrier of adjacent units.

    Product
    A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2013·2013-05-15

    Baxter Recalls Non-DEHP Catheter Extension Sets Due to Sterile Barrier Compromise

    Baxter Healthcare is recalling specific lots of Non-DEHP Catheter Extension Set Kits because separating packages can compromise the sterile barrier of adjacent units.

    Product
    A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; B) Product Code 2N8221: Non-DEHP Cathe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1269-2013·2013-05-15

    Baxter Recalls Non-DEHP Y-Type Catheter Extension Sets Due to Sterility Compromise

    Baxter Healthcare is recalling 228,200 units of Non-DEHP Y-Type Catheter Extension Sets because separating packages can compromise the sterile barrier of adjacent units.

    Product
    A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1271-2013·2013-05-15

    Baxter Recalls Non-DEHP Y-Type Catheter Extension Set Kits

    Baxter Healthcare is recalling 513,000 units of IV extension tubing kits because separating packages can compromise the sterile barrier.

    Product
    A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the administrat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0012-2013·2012-10-17

    Baxter Buretrol Solution Set Recalled for Potential Air Inflow

    Baxter is recalling Buretrol Solution Sets because the ball-valve feature may allow air to flow into the tubing at the completion of a dose.

    Product
    Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular acces
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0014-2013·2012-10-17

    Baxter Recalls Clearlink Buretrol Solution Sets Due to Valve Malfunction

    Baxter Healthcare is recalling Clearlink Buretrol Solution Sets because the ball-valve feature may fail, allowing air to enter the tubing.

    Product
    Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0015-2013·2012-10-17

    Baxter Recalls Clearlink System Buretrol Solution Sets Due to Valve Malfunction

    Baxter Healthcare is recalling 488,504 units of Clearlink System Buretrol Solution Sets because the ball-valve feature may allow air to enter the tubing.

    Product
    Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device Product Usage: The device is used for the administration of fluids from a container into the patient's vascular
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0013-2013·2012-10-17

    Baxter Buretrol Solution Set Recalled Due to Ball-Valve Malfunction

    Baxter Healthcare is recalling Buretrol Solution Sets because the ball-valve feature may allow air to flow into the tubing.

    Product
    Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1688-2012·2012-10-03

    Baxter Recalls 5% Dextrose and 0.45% Sodium Chloride Injection Due to Chemical Contamination

    Baxter Healthcare is recalling 5,064 containers of 5% Dextrose and 0.45% Sodium Chloride Injection USP due to potential trace levels of cumene hydroperoxide.

    Product
    5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1689-2012·2012-10-03

    Baxter Recalls 0.9% Sodium Chloride Injection Due to Chemical Contamination

    Baxter Healthcare is recalling 0.9% Sodium Chloride Injection USP in AVIVA containers due to potential trace levels of cumene hydroperoxide.

    Product
    0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1686-2012·2012-10-03

    Baxter Recalls 5% Dextrose Injection Due to Chemical Contamination

    Baxter Healthcare is recalling 5% Dextrose Injection USP in AVIVA containers due to potential trace levels of cumene hydroperoxide.

    Product
    5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1690-2012·2012-10-03

    Baxter Recalls Lactated Ringer's Injection Due to Chemical Contamination

    Baxter Healthcare is recalling specific lots of Lactated Ringer's Injection USP due to potential trace levels of cumene hydroperoxide.

    Product
    Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1687-2012·2012-10-03

    Baxter Recalls 10% Dextrose Injection Due to Chemical Contamination

    Baxter Healthcare is recalling 2,976 containers of 10% Dextrose Injection USP due to potential trace levels of cumene hydroperoxide.

    Product
    10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2268-2012·2012-09-05

    Baxter Mini-Infuser 150XL Infusion Pump Recalled for Battery Contact Defect

    Baxter Healthcare is recalling Mini-Infuser Model 150XL infusion pumps because a battery contact defect may prevent the device from operating.

    Product
    Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage:
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2269-2012·2012-09-05

    Baxter Mini-Infuser Model 300XL Infusion Pump Recalled for Battery Contact Defect

    Baxter Healthcare is recalling 19,380 Mini-Infuser Model 300XL infusion pumps because a battery contact defect may prevent the device from operating.

    Product
    Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector switch; product codes 2M8171 and 2M8171R. Product Usage: These product codes includes refurbished units. Intended for the controlled
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2139-2012·2012-08-15

    Baxter Recalls Automix High Speed Compounder Systems Due to Electrical Failures

    Baxter Healthcare is recalling 270 Automix High Speed Compounder Systems worldwide due to potential electrical failures and incorrect device responses.

    Product
    AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2141-2012·2012-08-15

    Baxter Recalls Automix 3+3 Compounder Systems Due to Electrical Failures

    Baxter Healthcare is recalling 3,106 Automix 3+3 Compounder Systems because fluid ingress can cause incorrect responses, unexpected pump operations, or silent stops.

    Product
    AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2142-2012·2012-08-15

    Baxter Recalls Automix 3+3 Compounders Due to Electrical Failures

    Baxter Healthcare is recalling 950 Automix 3+3 Compounders because fluid ingress can cause incorrect responses, unexpected pump operations, or silent stops.

    Product
    AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nut
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2140-2012·2012-08-15

    Baxter Recalls Automix Plus High Speed Compounder Systems

    Baxter Healthcare is recalling 840 Automix Plus High Speed Compounder Systems due to electrical failures that may cause incorrect responses or undetected stops.

    Product
    AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulat
    Category
    Medical Device
    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.