—#204212

Product

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

FDA product code: FKX — System, Peritoneal, Automatic Delivery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K151525
Affected lot / code info: 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

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Timeline

Recall initiated: 2023-11-15
Posted by FDA: 2023-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204212. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.