FDA recall Z-1150-2021

Product

Infusion Pump

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.

Key facts

Status

Terminated

Initiation date

2021-01-06

Report date

2021-03-03

Termination date

2026-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Medina, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1150-2021