Device product
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.
Z-0088-2019
Product summary
- Event
- Event 80972
- Status
- Terminated
- Classification
- Class II
- Quantity
- 113,302 units
- Official record key
device-enforcement:Z-0088-2019
Official wording
Reason: Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.
Code information: Lot numbers: a) NONUNNA3: 70112, 70485, 70602, 80637, 80663, and 80719. b) NONUNNA4: 70182, 70593, 80638, 80644, 80660, 80709 and 80712.
Distribution pattern: United States, Taiwan, Chile
Derived failure modes
-
Unknown
Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.