FDAClass IIOctober 17, 2018

Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and recall: Mold

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.

Why was Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers: a) NONUNNA3: 70112, 70485, 70602, 80637, 80663, and 80719. b) NONUNNA4: 70182, 70593, 80638, 80644, 80660, 80709 and 80712.

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.
Recalling firm
MEDLINE INDUSTRIES INC
Quantity
113,302 units
Distribution
United States, Taiwan, Chile
Recall date
October 17, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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