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Recall Observatory FDA recall evidence

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

August 30, 2018

Class II

Product summary

Firm
MEDLINE INDUSTRIES INC
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

    reason.no_named_rule · v1.0.0

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