Recall Z-0550-2024
Baxter Healthcare Corporation · initiated November 15, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Codes / lots: 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
Reason for recall
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-0550-2024
- Initiated
- November 15, 2023
- Posted by FDA
- December 14, 2023
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- Quantity
- 339,936 devices
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL