Recall Z-0672-2017 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring
| Date | Sep 28, 2016 |
| Status | Terminated |
| Reason | A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Case Assembly in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely. |
| Root cause | Process control |
| Action | Baxter sent an Urgent Medical Device Correction letter dated September 28, 2016, to all affected customers. On 10/27/2016, Baxter Healthcare sent a f/u UMDC Letter (dated 10/27/2016) to customers. The f/u letter contains the device correction plan which states that Baxter will be replacing at no charge the rear case assembly on all affected Sigma Spectrum Infusion Pumps, as well as affected stand-alone rear case assemblies shipped to customers as spare parts. For questions, please contact your Baxter sales representative, or Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday t |
| Quantity | 439 units |
| Distribution | Nationwide Distribution, 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 |