FDA Recall
Terminated
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.
Recall: Z-0088-2019
·
Initiated August 30, 2018
Recall
- Recall Number
- Z-0088-2019
- Event Number
- 80972
- Firm
- MEDLINE INDUSTRIES INC
- FEI Number
- 1417592
- Product Code
- NEC
- Status
- Terminated
- Root Cause
- Environmental control
- Initiated
- August 30, 2018
- Terminated
- February 9, 2023
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753
Description
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.
Reason
Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.
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.
Distribution
United States, Taiwan, Chile
Quantity
113,302 units