Baxter Amia Automated Peritoneal Dialysis recall
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Why was Baxter Amia Automated Peritoneal Dialysis recalled?
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 339,936 devices
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall date
- December 20, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)