Recall Z-0088-2019 ยท NEC Bandage, Liquid, Skin Protectant
MEDLINE INDUSTRIES INC
Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4 Product is packaged in a foil pouch, which is inserted in a box carton. There are 12 cartons in each case.
| Date | Aug 30, 2018 |
| Status | Terminated |
| Reason | Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold. |
| Root cause | Environmental control |
| Action | On August 30, 2018, Medline sent Immediate Action Required letters to all of their consignees. Each letter was accompanied by an Urgent Remedial Action Destruction Form which was to be completed and returned to the firm. |
| Quantity | 113,302 units |
| Distribution | United States, Taiwan, Chile |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.