FDA-Device2018-10-17Class II
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.
MEDLINE INDUSTRIES INC
Hazard
Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.
Sold states
United States, Taiwan, Chile
Affected count
113,302 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0088-2019Don't want to check this manually?
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