Class 2 Device Recall EVENCARE G3 Blood Glucose Test Strips

• Date Initiated by Firm: September 18, 2019
• Create Date: November 22, 2019
• Recall Status: Terminated on May 06, 2022
• Recall Number: Z-0513-2020
• Recall Event ID: 83890
• 510(K)Number: K120448
• Product Classification: Glucose oxidase, glucose - Product Code CGA
• Product: EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.
• Code Information: Model Number: MPH3550FL, Lot number: 16819023001, Expiration Date: 11/12/2020
• Recalling Firm/ Manufacturer: Medline Industries Inc; Three Lakes Drive; Northfield IL 60093
• For Additional Information Contact: Benjamin Gora; 886-359-1704
• Manufacturer Reason for Recall: Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips.
• FDA Determined Cause: Packaging process control
• Action: 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.
• Quantity in Commerce: 761 boxes (38,050 foil pouches)
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CGA