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
    • H23F23028
    • H23G11054
    • H23F24018
    • H23G12029
    • H23F24034
    • H23G13100
    • H23F24067
    • H23G14074
    • H23F25049
    • H23G15048
    • H23F25056
    • H23G16038
    • H23F26047
    • H23G17051
    • H23F26054
    • H23G18067
    • H23F27037
    • H23G19115
    • H23F27045
    • H23G20055
    • H23F27102
    • H23G22069
    • H23F28035
    • H23G23067
    • H23F28043
    • H23G24107
    • H23F29066
    • H23G25047
    • H23F30064
    • H23G25096
    • H23G01030
    • H23G26094
    • H23G02046
    • H23G27100
    • H23G05015
    • H23G28082
    • H23G06047
    • H23G30054
    • H23G07052
    • H23G31110
    • H23G08050
    • H23H04032
    • H23G09058
    • H23H05039
    • H23G10072
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.