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 |
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