Z-0088-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 17, 2018
- Initiation Date
- August 30, 2018
- Termination Date
- February 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 113,302 units
Product 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 for Recall
Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.
Distribution Pattern
United States, Taiwan, Chile
Code Information
Lot numbers: a) NONUNNA3: 70112, 70485, 70602, 80637, 80663, and 80719. b) NONUNNA4: 70182, 70593, 80638, 80644, 80660, 80709 and 80712.