Baxter Healthcare Corporation Recall 88351
Description: Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Baxter Healthcare Corporation Recall 88351 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2379-2021 |
| Event ID | 88351 |
| Event Description | Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies. |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 1976 units |
| Recall Reason | Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter Data was manipulated to appear to be conforming |
| Device Classification | 20210908 |
| Device Code Info | Lot Numbers: 20B2330M |
| Center Classification Date | 20210827 |
| Recall Initiation Date | 20210722 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
| Similar To |