Medivators, Inc. Recall 87894
Description: Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
Medivators, Inc. Recall 87894 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1859-2021 |
| Event ID | 87894 |
| Event Description | Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI. |
| Quantity | 1,381 CASES |
| Recall Reason | The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation. |
| Device Classification | 20210623 |
| Device Code Info | Lot 489224 |
| Center Classification Date | 20210615 |
| Recall Initiation Date | 20210420 |
| Recalling Firm | Medivators, Inc. |
| Initial Notification | Telephone |
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