Z-0513-2020Class II

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

Name: Z-0513-2020 EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case
Creator: Medline Industries Inc
Published: 2019-09-18
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2019-09-18 / Terminated / root cause: packaging

FDA source

Medline Industries Inc began a recall of EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case on 2019-09-18. FDA classified it as Class II and gives the reason as "Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0513-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-18
Posted: 2019-11-22
Terminated: 2022-05-06
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips.
Root cause tag: packaging
FDA root 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.
Product codes and lots: Model Number: MPH3550FL, Lot number: 16819023001, Expiration Date: 11/12/2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0513-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0513-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22

Product code CGA

K120448Class IIMeg-2B Blood Glucose Monitoring System, Pro Blood Glucose Monitoring System, Blood Glucose Test Strips, Glucose ControlApex BioTechnology Corp. / cleared 2012-04-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)