Recalls / —

—#176684

Product

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

FDA product code

CGA — Glucose Oxidase, Glucose

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K120448

Affected lot / code info

Model Number: MPH3550FL, Lot number: 16819023001, Expiration Date: 11/12/2020

Why it was recalled

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

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm

Medline Industries Inc

Address

Three Lakes Drive, Northfield, Illinois 60093

Distribution

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.

Timeline

Recall initiated

2019-09-18

Terminated

2022-05-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #176684. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.