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U.S. Department of Health and Human Services

Class 2 Device Recall EVENCARE G3 Blood Glucose Test Strips

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  Class 2 Device Recall EVENCARE G3 Blood Glucose Test Strips see related information
Date Initiated by Firm September 18, 2019
Create Date November 22, 2019
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = APEX BIOTECHNOLOGY CORP.
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