Z-1150-2021Class II

Infusion Pump

Name: Z-1150-2021 Infusion Pump
Creator: Baxter Healthcare Corporation
Published: 2021-01-06
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2021-01-06 / Terminated

FDA source

Baxter Healthcare Corporation began a recall of Infusion Pump on 2021-01-06. FDA classified it as Class II and gives the reason as "Battery performance issues related to prolonged storage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1150-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-06
Posted: 2021-02-25
Terminated: 2026-05-04
Recalling firm: Baxter Healthcare Corporation
Product: Infusion Pump
Product code: FRN Pump, Infusion
Reason for recall: Battery performance issues related to prolonged storage.
FDA 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 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
Quantity in commerce: 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, St. Thomas, Guyana, Trinidad and Tobago, Jamaica and Nassau Bahamas.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1150-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1150-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-25

Product code FRN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)