EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.
- Company
- Medline Industries Inc
- Recall Initiated
- September 18, 2019
- Terminated
- May 6, 2022
- Recall Number
- Z-0513-2020
- Quantity
- 761 boxes (38,050 foil pouches)
- Firm Location
- Northfield, IL
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.
Lot / Code Info
Model Number: MPH3550FL, Lot number: 16819023001, Expiration Date: 11/12/2020
Root Cause
Packaging process control
Action Taken
Medline Industries, Inc. notified customers on about 09/18/2019, via "URGENT RECALL IMMEDIATE ACTION REQUIRED" letter. Customers were informed that the heat activated adhesive used to seal the foil pouch was not fully cured during the manufacturing process. As a result, an incomplete seal and premature expiration of the individually packaged Blood Glucose Test Strips has occurred. Inspection using EVENCARE G3 control solution and unused Blood Glucose Test Strips, from the affected lot, has shown that the test strips can produce inaccurate blood glucose readings. Instructions included to immediately check inventory for the affected item and lot number, quarantine affected product, complete and return the enclosed response form, arrange for the return of all affected product, and notify customers if the product was further distributed. Questions can be directed to 866-359-1704.