Recall Z-0120-2021 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
| Date | Oct 22, 2020 (initiated Jun 30, 2020) |
| Status | Terminated |
| Reason | Baxter is updating the device IFU for safety communication regarding cleaning practices. |
| Root cause | Labeling design |
| Action | A Safety Alert communication was sent to affected customers on 04/01/2020 via USPS First Class Mail. A follow-up Urgent Device Correction communication was sent to all affected customers on 8/28/2020 via USPS first class mail. The customer communications reiterate instructions for use listed in the Operator's Manual. Baxter is asking customers to: 1) Operators may continue to safely use the infusion pumps while following the instructions for cleaning provided in the Operator's Manual. An electronic copy of the Operator's Manual can be accessed at https://service.baxter.com. In addition, |
| Quantity | 9352 units |
| Distribution | Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana) |
| 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 |