—#152270

Product

Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds

FDA product code: FQM — Bandage, Elastic
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: Unit Numbers: NONUNNA3 & NONUNNA4 Lot Numbers: 52581 through 63599

Why it was recalled

Medline Industries, Inc is recalling Unna Z Unna Boot Bandage 3X10 and Unna Z Unna Boot Bandage 4X10 due to contamination of the products with common mold (Cladosporium sphaerospermum/cladosporioides/herbarum/phaenocomae/halotolerans and Penicillium corylophilum)..

Root cause (FDA determination)

Environmental control

Action the firm took

Medline Industries sent an Immediate Action letter dated November 23, 2016, to all affected customers with response forms to their customers. Customers were instructed to destroy the affected Unna Boot Bandages. Affected lots of product remaining at the firm's distribution centers have been placed on hold and quarantined pending destruction. All affected product will be destroyed. For further questions, please call (847) 643-3245.

Recalling firm

Firm: Medline Industries Inc
Address: 1 Medline Pl, Mundelein, Illinois 60060-4485

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and to the countries of : Chile, Peru, El Salvador and Taiwan.

Timeline

Recall initiated: 2016-11-23
Terminated: 2019-07-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152270. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.