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Recall Observatory FDA recall evidence

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

September 18, 2019

Class II

Product summary

Firm
Medline Industries Inc
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

    reason.labeling_packaging · v1.0.0

    Incomplete seal