Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Reported: December 20, 2023 Initiated: November 15, 2023 #Z-0550-2024
Product Description
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Reason for Recall
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 339,936 devices
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479. Recalled by Baxter Healthcare Corporation. Units affected: 339,936 devices.
Why was this product recalled? ▼
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 20, 2023. Severity: Moderate. Recall number: Z-0550-2024.
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