Infusion Pump
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- January 6, 2021
- Recall Number
- Z-1150-2021
- Quantity
- 589,704 total units
- Firm Location
- Medina, NY
Reason for Recall
Battery performance issues related to prolonged storage.
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, St. Thomas, Guyana, Trinidad and Tobago, Jamaica and Nassau Bahamas.
Lot / Code Info
Infusion Pump Product codes: 35700ABB, 35700BAX, and 35700BAX2 Battery codes: 35083, 35162, 35195, and 35724. Infusion Pump Product codes: 35700ABB, 35700BAX, 35700BAX2 3570009 Battery codes: 35223 and 36010
Root Cause
Under Investigation by firm
Action Taken
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 indicated. If you are experiencing recurrent battery alerts/alarms, please operate your pumps on AC power and contact Baxter Technical Assistance at 800-356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time. 3.Baxter is advising all customers who plan prolonged storage of Spectrum pumps and batteries to ensure the following: Batteries are charged to 2 or 3 bars prior to storage (do not fully charge); Batteries are stored between -10 and +35 degrees C (14 and 95 degrees F); Batteries are removed from the pump and stored independent of the pumps; and Batteries are recharged every six months while in storage. Not following these storage instructions can result in battery damage and/or reduced capacity and life of the battery. 4. The Spectrum Installation & Maintenance Guide/Service Manual, which can be accessed at https://service.baxter.com/tsportal/, describes a Battery Life Test that can be used to test for battery damage due to depletion. This test is recommended as part of routine maintenance. 5. Customers experiencing recurrent battery alerts/alarms should follow the instructions described in step 2 above. Do not attempt to resolve this issue by performing the battery recovery as described in the Technical Service Bulletins below. The battery recovery process is intended to recover a battery locked in a low c