FDA Recall Terminated

Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10)0000000000 (17)000000(30)20 Packaged for Medline Industries, Inc., Northfield, IL 60093 USA. 1-800-MEDLINE www.medline.com WINGED SPONGE:Made in Mexico

Recall: Z-0865-2020 · Initiated January 7, 2020

Recall

Recall Number
Z-0865-2020
Event Number
84665
Firm
Medline Industries Inc
FEI Number
1417592
Product Code
LRP
Status
Terminated
Root Cause
Packaging
Initiated
January 7, 2020
Terminated
September 16, 2020
Address
Three Lakes Drive, Northfield, IL, 60093

Description

Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10)0000000000 (17)000000(30)20 Packaged for Medline Industries, Inc., Northfield, IL 60093 USA. 1-800-MEDLINE www.medline.com WINGED SPONGE:Made in Mexico

Reason

There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.

Action

Consignees notified by first class mail with formal recall letter dated January 07, 2020. The letter identified affected product, stated reason for recall, and requested product to be quarantined. A response form was requested to be returned via email.

Distribution

Kentucky. No governmental, Canadian, or Mexican consignees.

Quantity

500