Recall Z-1487-2021 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
| Date | Mar 19, 2021 |
| Status | Terminated |
| Reason | Potentially defective component in the AC power adapter which may fail over time. |
| Root cause | Device Design |
| Action | On 3/19/2020 the firm sent a letter to its customers with the following instructions: 1. Operators may continue to use the Spectrum IQ Infusion Pumps until the correction is completed. If using an impacted pump to infuse critical medication such as vaso-active medications, ensure there is a back-up pump available in case the power adapter fails. 2. A local Baxter service representative will contact your facility to provide a list of affected serial numbers at your facility and to coordinate power adapter replacement. Your facility will be receiving this power adapter from Baxter at no charge. |
| Quantity | 408 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CT, FL, IA, IN, LA, MA, MD, ME, MN, MO, MS, MT, NC, NJ, NY, OH, PA, RI, SC, TN, TX and the country of Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software Baxter Healthcare Corporation, May 11, 2018 |