Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
FDA device recall Z-0550-2024 · posted 2023-12-14 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- FKX
- Quantity affected
- 339,936 devices
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Date initiated
- 2023-11-15
- Date posted
- 2023-12-14
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Amia Automated PD System with Sharesource (K151525) | Deka Research and Development | 2015-10-09 |