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