Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine recalled over mold contamination

Recall date

August 30, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

MEDLINE INDUSTRIES INC recalls Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4 Product is p…

Recall number

Z-0088-2019

FDA classification

Class II

Brand / firm

MEDLINE INDUSTRIES INC

Sold / distributed

United States, Taiwan, Chile

Why it was recalled

Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.