—#167154

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.

FDA product code: NEC — Bandage, Liquid, Skin Protectant
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: Lot numbers: a) NONUNNA3: 70112, 70485, 70602, 80637, 80663, and 80719. b) NONUNNA4: 70182, 70593, 80638, 80644, 80660, 80709 and 80712.

Why it was recalled

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

Root cause (FDA determination)

Environmental control

Action the firm took

On August 30, 2018, Medline sent Immediate Action Required letters to all of their consignees. Each letter was accompanied by an Urgent Remedial Action Destruction Form which was to be completed and returned to the firm.

Recalling firm

Firm: MEDLINE INDUSTRIES INC
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: United States, Taiwan, Chile

Timeline

Recall initiated: 2018-08-30
Terminated: 2023-02-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167154. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.