Z-0513-2020 Class II Terminated
FDA device recall Z-0513-2020 was initiated by Medline Industries Inc on September 18, 2019 and is designated Class II. Reason for recall: Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips. The recall status is terminated (terminated May 6, 2022). Affected quantity: 761 boxes (38,050 foil pouches).
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2019
- Initiation Date
- September 18, 2019
- Termination Date
- May 6, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 761 boxes (38,050 foil pouches)
Product Description
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 Pattern
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.
Code Information
Model Number: MPH3550FL, Lot number: 16819023001, Expiration Date: 11/12/2020