Fresenius Medical Care Holdings, Inc. Recall 90438
Description: NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
Fresenius Medical Care Holdings, Inc. Recall 90438 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1371-2022 |
| Event ID | 90438 |
| Event Description | NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2 |
| Product Type | Devices |
| Distribution | Natiowide |
| Quantity | 163 cases |
| Recall Reason | Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use |
| Device Classification | 20220720 |
| Device Code Info | UDI-DI: (01) 10840861101757 (17) 240331 (10) 22CTAC102 Lot Number: 22CTAC102 Exp Date: 2024-03-31 |
| Center Classification Date | 20220712 |
| Recall Initiation Date | 20220531 |
| Recalling Firm | Fresenius Medical Care Holdings, Inc. |
| Initial Notification | Letter |
| Similar To |