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U.S. Department of Health and Human Services

Class 2 Device Recall Amia Automated PD Set with Cassette

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 Class 2 Device Recall Amia Automated PD Set with Cassettesee related information
Date Initiated by FirmNovember 15, 2023
Date PostedDecember 14, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0550-2024
Recall Event ID 93376
510(K)NumberK151525 
Product Classification System, peritoneal, automatic delivery - Product Code FKX
ProductBaxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Code Information 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
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactBaxter Renal Home Care Services
800-284-4060
Manufacturer 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 2		Process control
ActionBaxter 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.
Quantity in Commerce339,936 devices
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FKX
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