Baxter Healthcare Corporation
190 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Baxter Healthcare Corporation and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-07-19FDA-DeviceClass IThe Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.
- 2023-07-19FDA-DeviceClass ISIGMA Spectrum Infusion Pump, Product Code 35700BAX2
A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.
- 2023-07-05FDA-DeviceClass IINaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail position, brakes off, height of bed changes, head of bed angle, and/or turn reminders) are turned off.
- 2023-07-05FDA-DeviceClass IIVoalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail position, brakes off, height of bed changes, head of bed angle, and/or turn reminders) are turned off.
- 2023-05-10FDA-DeviceClass IIHill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q) P7923A03, r) P7923A04, s) P7924A01, t) P7924A02, u) P7924A03, v) P7924A04, w) P7924ARENT01
There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).
- 2023-05-03FDA-DeviceClass IIGEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
The product is brittle and potentially crumbling upon handling or when being removed from its package.
- 2023-05-03FDA-DrugClass IIDianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
- 2023-05-03FDA-DrugClass IIDianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code L5B4826, NDC 0941-0409-07; and b) 6000 mL per Ambu-Flex II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
- 2023-04-26FDA-DeviceClass IIExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe
ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.
- 2023-04-05FDA-DeviceClass IIAutomated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
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