Recall Z-0513-2020— Medline Industries Inc

Name: FDA recall Z-0513-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-18

Class II · Terminated

Class II FDA medical device recall by Medline Industries Inc, initiated 2019-09-18, terminated 2022-05-06. It names one FDA 510(k) clearance: K120448. Product: EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.. Reason: Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips..

Recalling firm: Medline Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2019-09-18
Terminated: 2022-05-06
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K120448 — MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROLApex BioTechnology Corp.·cleared 2012-04-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.