Medical DeviceJun 10, 2020
Baxter Healthcare Gambro Cartridge Low Weight-Low Volume Blood Transport System for recall — FDA Z-2196-2020
Potential disconnection of tubing set.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Recall history in this database
Classification mix: Class II: 260, Class I: 60, Class III: 8.
Medical DeviceJun 10, 2020
Baxter Healthcare Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for recall — FDA Z-2193-2020
Potential disconnection of tubing set.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceJun 10, 2020
Baxter Healthcare Gambro Cartridge Blood Transport System for Hemodialysis Blood Set recall — FDA Z-2194-2020
Potential disconnection of tubing set.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceJun 10, 2020
Baxter Healthcare Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood recall — FDA Z-2195-2020
Potential disconnection of tubing set.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceApr 15, 2020
Baxter Healthcare GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended recall — FDA Z-1686-2020
The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceApr 15, 2020
Baxter Healthcare GEM Microvascular Anastomotic Coupler Devices s intended to be used in the recall — FDA Z-1687-2020
The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceApr 15, 2020
Baxter Healthcare GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended recall — FDA Z-1685-2020
The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceJan 15, 2020
Baxter Healthcare Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519 recall — FDA Z-0793-2020
Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJan 15, 2020
Baxter Healthcare ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310 recall — FDA Z-0794-2020
Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceNov 13, 2019
Baxter Healthcare Prismaflex Control Unit, software versions below 7.21 recall — FDA Z-0276-2020
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceNov 13, 2019
Baxter Healthcare Prismaflex Control Unit, software versions below 7.21 recall — FDA Z-0277-2020
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceNov 13, 2019
Baxter Healthcare Prismaflex Control Unit, software versions below 7.21 recall — FDA Z-0279-2020
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceNov 13, 2019
Baxter Healthcare Prismaflex Control Unit, software versions below 7.21 recall — FDA Z-0280-2020
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceNov 13, 2019
Baxter Healthcare Prismaflex Control Unit, software versions below 7.21 recall — FDA Z-0278-2020
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceNov 6, 2019
Baxter Healthcare TherMax Blood Warmer Unit recall — FDA Z-0247-2020
TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceOct 30, 2019
Baxter Healthcare EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following recall — FDA Z-0167-2020
Potential ability to leak once used for compounding.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceOct 16, 2019
Baxter Healthcare EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x recall — FDA Z-0050-2020
Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.
Class IIIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceOct 9, 2019
Baxter Healthcare L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic recall — FDA Z-0030-2020
Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. A leaking cassette could lead to contamination of the sterile…
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceJul 10, 2019
Baxter Healthcare REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear recall — FDA Z-1909-2019
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceJul 10, 2019
Baxter Healthcare REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear recall — FDA Z-1908-2019
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceMay 8, 2019
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code recall — FDA Z-1248-2019
The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time.…
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceFeb 27, 2019
Baxter Healthcare Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended recall — FDA Z-0850-2019
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceFeb 27, 2019
Baxter Healthcare AMIA Automated Peritoneal Dialysis System Product Usage: It is intended recall — FDA Z-0849-2019
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
Class IIFDA: TerminatedBaxter Healthcare Corporation
DrugJan 16, 2019
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL recall — FDA D-0351-2019
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Understanding this recall history
This page summarizes recall records in which the official source identifies Baxter Healthcare Corporation 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.