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Class 2 Device Recall Amia Automated PD Set with Cassette |
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Date Initiated by Firm |
November 15, 2023 |
Date Posted |
December 14, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0550-2024 |
Recall Event ID |
93376 |
510(K)Number |
K151525
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Product Classification |
System, peritoneal, automatic delivery - Product Code FKX
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Product |
Baxter 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
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For Additional Information Contact |
Baxter Renal Home Care Services 800-284-4060
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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.
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FDA Determined Cause 2 |
Process control |
Action |
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. |
Quantity in Commerce |
339,936 devices |
Distribution |
Worldwide distribution - US Nationwide and the country of Canada. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = FKX and Original Applicant = DEKA RESEARCH AND DEVELOPMENT
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