FDA Medical Device Recalls (openFDA)
Medline Industries Inc: EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.
- Recall number
- Z-0513-2020
- Recalling firm
- Medline Industries Inc
- Product
- EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.
- Status
- Terminated
- Initiated
- 2019-09-18
- Posted
- not on file
- Terminated
- 2022-05-06
- Reason
- Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips.
- 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
- 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.
- Lot, serial or model codes
- Model Number: MPH3550FL, Lot number: 16819023001, Expiration Date: 11/12/2020
- 510(k) numbers
- ["K120448"]
- PMA numbers
- not on file
- Product code
- CGA
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28