FDA recall Z-0513-2020

Medline Industries Inc · Class II · device

Product

EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.

Reason for recall

Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips.

Distribution

Nationwide distribution to CA, CT, GA, ID, IL, IN, KS, MA, MI, MN, MO, MS, NV, OH, OR, SC, TN, TX, UT, WA, WI, WY.

Key facts

Status
Terminated
Initiation date
2019-09-18
Report date
2019-12-04
Termination date
2022-05-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0513-2020