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Recall Observatory FDA recall evidence

Device product

Infusion Pump

Z-1150-2021

January 06, 2021

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 86788
Status
Terminated
Classification
Class II
Quantity
589,704 total units
Official record key
device-enforcement:Z-1150-2021

Official wording

Reason: Battery performance issues related to prolonged storage.

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Battery performance issues related to prolonged storage.