Recall Z-0865-2020 ยท LRP Tray, Surgical
Medline Industries Inc
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
| Date | Jan 7, 2020 |
| Status | Terminated |
| Reason | There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier. |
| Root cause | Packaging |
| 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. |
| Quantity | 500 |
| Distribution | Kentucky. No governmental, Canadian, or Mexican consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.