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

Hazard

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

Details from the source

Reason for recall: There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Quantity: 339,936 devices 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

UPC codes

0085412153186

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.