Reported Dec 20, 2023 · Ongoing
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
- Lot codes and dates
- UDI/DI 0085412153186
- Lot Numbers
H23F23028H23G11054H23F24018H23G12029H23F24034H23G13100H23F24067H23G14074H23F25049H23G15048H23F25056H23G16038H23F26047H23G17051H23F26054H23G18067H23F27037H23G19115H23F27045H23G20055H23F27102H23G22069H23F28035H23G23067H23F28043H23G24107H23F29066H23G25047H23F30064H23G25096H23G01030H23G26094H23G02046H23G27100H23G05015H23G28082H23G06047H23G30054H23G07052H23G31110H23G08050H23H04032H23G09058H23H05039H23G10072
- Amount recalled
- 339,936 devices
Where it was sold
- Nationwide
Why it was recalled
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
This product could cause temporary or reversible health problems — stop using it.
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