Recall Z-0971-2018 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
| Date | Oct 6, 2017 |
| Status | Terminated |
| Reason | Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Medical Device Correction, dated October 6, 2017, was sent to customers. The letter described the problem, identified the affected device, discussed the hazard involved, and action to be taken. Customers were asked to locate the affected products at their facility. Customers should continue to follow the instructions in document 41394 Rev. A, PREVENTIVE MAINTENANCE, for their entire fleet of pumps. Baxter will inspect affected pumps. To arrange for return of devices that have failed the flow rate accuracy test, contact Baxter Healthcare Medina. If you are a dealer, wholesaler, |
| Quantity | 173,375 |
| Distribution | Worldwide Distribution - US, including the District of Columbia, Puerto Rico, and Canada. |
| 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 |