Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
Recall
- Recall Number
- Z-1487-2021
- Event Number
- 87568
- Firm
- Baxter Healthcare Corporation
- FEI Number
- 1314492
- Product Code
- FRN
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- March 19, 2021
- Terminated
- July 15, 2022
- Address
- 711 Park Ave, Medina, NY, 14103-1036
Description
Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
Potentially defective component in the AC power adapter which may fail over time.
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. 3. Upon receipt of the new power adapters, refer to the Spectrum IQ Installation and Maintenance Manual (41019v900 Rev F, Section 11.2) for instructions on how to remove and replace the power adapter on the impacted pumps. The manual can be found on Baxters Technical Service Portal at https://service.baxter.com. 4. After the installation of the new power adapters, please return the original power adapters to Baxter using the packaging from the replacement power adapter and the provided return label. 5. If you received this notification directly from Baxter, complete the enclosed Baxter Customer Reply Form and return it to Baxter by e-mailing it to [email protected]. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. If you do not return the customer reply form, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 6. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. 7. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 8. If you are a de
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.
408 units