| | Class 2 Device Recall Dialysate Concentrate for HemodialysisLiquid/Powd |  |
| Date Initiated by Firm | April 20, 2021 |
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| Create Date | June 15, 2021 |
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| Recall Status1 |
Terminated 3 on July 11, 2024 |
| Recall Number | Z-1859-2021 |
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| Recall Event ID |
87894 |
| 510(K)Number | K843963 |
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| Product Classification |
System, dialysate delivery, central multiple patient - Product Code FKQ
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| Product | Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine. |
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| Code Information |
Lot 489224 |
| FEI Number |
2150060
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Recalling Firm/
Manufacturer |
Medivators, Inc.
14605 28th Ave N
Plymouth MN 55447-4822
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| For Additional Information Contact | Medivators Customer Care
763-553-3300 |
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Manufacturer Reason
for Recall | The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation. |
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FDA Determined
Cause 2 | Process control |
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| 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 custserv@medivators.com 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 happy-sarah.kim@cantel.com
4. If this product was further distributed, notify your customer of the recall. |
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| Quantity in Commerce | 1,381 CASES |
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| Distribution | US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI. |
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| 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = FKQ
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