Baxter Healthcare Corporation Recall 90841
Description: Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
Baxter Healthcare Corporation Recall 90841 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0085-2023 |
| Event ID | 90841 |
| Event Description | Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies. |
| Product Type | Devices |
| Distribution | US Nationwide |
| Quantity | 29,764 devices |
| Recall Reason | Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions. |
| Device Classification | 20221019 |
| Device Code Info | UDI 07332414089443, All Lot Codes |
| Center Classification Date | 20221012 |
| Recall Initiation Date | 20220914 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
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