Recall Z-1368-2026 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
| Date | Feb 13, 2026 (initiated Jan 13, 2026) |
| Status | Open, Classified |
| Reason | Pumps were released without full testing being performed, including occlusion alarm testing. |
| Root cause | Employee error |
| Action | Firm notified the single customer on 1/13/26 via phone call. Customer was asked to work with on-site service technician to coordinate return of affected product. |
| Quantity | 5 |
| Distribution | States: Ohio Countries: United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) Baxter Healthcare Corporation, Jul 28, 2025 |