Recall Z-1150-2021 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Infusion Pump
| Date | Jan 6, 2021 |
| Status | Terminated |
| Reason | Battery performance issues related to prolonged storage. |
| Root cause | Under Investigation by firm |
| Action | 1. If your facility is currently installing or planning to install new pumps and batteries that are currently in storage, please contact Baxter Technical Assistance at 800 356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time, for further instructions. The duration and conditions under which the new batteries have been stored will help determine whether battery damage due to depletion is likely. 2. For facilities currently using Spectrum pumps: If you are not experiencing recurrent battery alerts/alarms, continue using the Spectrum battery modules as indic |
| Quantity | 589,704 total units |
| Distribution | Domestic Distribution: ST, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico. International Distribution: Canada, Barbados, Bermuda |
| FDA record | Open on fda.gov |