Device product
EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.
Z-0513-2020
Product summary
- Event
- Event 83890
- Status
- Terminated
- Classification
- Class II
- Quantity
- 761 boxes (38,050 foil pouches)
- Official record key
device-enforcement:Z-0513-2020
Official wording
Reason: Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips.
Code information: Model Number: MPH3550FL, Lot number: 16819023001, Expiration Date: 11/12/2020
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.
Derived failure modes
-
Labeling or packaging
Incomplete seal