Recall Z-0670-2017 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- 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 duri
| Date | Sep 28, 2016 |
| Status | Terminated |
| Reason | A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library 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 | 5,976 units (US: 5972, Canada: 4) |
| Distribution | Nationwide Distribution, Puerto Rico and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042121 | SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY Sigma Intl., Aug 26, 2004 |