Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
FDA Recall Z-1859-2021 · Posted None
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Recalling FirmMedivators, Inc.
Recall StatusTerminated
Product CodeFKQ
Date Initiated2021-04-20
Date Terminated2024-07-11
Product Quantity1,381 CASES
Reason for Recall
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Firm Action
On 4/20/21 the firm initiated notification to its consignee via phone call, followed by a letter sent on 4/27/21 with the following instructions:
1. Quarantine and discontinue use of product from lot 489224, including dialysate produced with this lot of concentrate.
2. Contact Medivators Customer Service at 1-800-444-4729 or [email protected] to receive a return material authorization to return any unused product and receive replacement product.
3. Please return the enclosed Acknowledgement form via email to Happy-Sarah Kim at [email protected]
4. If this product was further distributed, notify your customer of the recall.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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