Device product
Infusion Pump
Z-1150-2021
Product summary
- 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
Battery performance issues related to prolonged storage.