Recall Z-1253-2025 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
| Date | Mar 6, 2025 (initiated Feb 5, 2025) |
| Status | Open, Classified |
| Reason | There is the potential for missing motor mounting screws, which may have occurred during the servicing process. |
| Root cause | Under Investigation by firm |
| Action | Baxter issued an "URGENT MEDICAL DEVICE RECAL" notice to its consignees on 02/05/2025 via US Mail. The notice explained the issue, hazard involved, and requested the following actions be taken: "1. Immediately locate, isolate, and cease all use of Spectrum pumps with the affected serial numbers. The product code and serial number can be found on the bottom of the infusion pump. 2. Contact Baxter to arrange for the return of the affected pumps for inspection and reservicing as applicable. 3. If you received this communication directly from Baxter, acknowledge receipt on the enclosed reply |
| Quantity | 66 units |
| Distribution | US: Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133801 | BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY Baxter Healthcare Corporation, May 7, 2014 |