Recall Z-1859-2021 ยท FKQ System, Dialysate Delivery, Central Multiple Patient
Medivators, Inc.
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
| Date | Apr 20, 2021 |
| Status | Terminated |
| Reason | The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation. |
| Root cause | Process control |
| 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 dis |
| Quantity | 1,381 CASES |
| Distribution | US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K843963 | DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD Renal Systems, Inc., Jan 7, 1985 |