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Open, Classified

Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479

FDA Recall Z-0550-2024 · Posted 2023-12-14

Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeFKX
Date Initiated2023-11-15
Product Quantity339,936 devices

Reason for Recall

There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.

Firm Action

Baxter issued an Urgent Medical Device Recall notice to its consignees on 11/15/2023 by US Mail. The notice explained the issue, potential risk, and requested the following: Isolate and cease all use of the affected units pending return.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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