Device product

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

Z-1074-2017

November 23, 2016

Class II

Product summary

Firm: Medline Industries Inc
Event: Event 76132
Status: Terminated
Classification: Class II
Quantity: 117,059 units
Official record key: device-enforcement:Z-1074-2017

Official wording

Reason: 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)..

Code information: Unit Numbers: NONUNNA3 & NONUNNA4 Lot Numbers: 52581 through 63599

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

Derived failure modes

Microbial contamination
reason.microbial_contamination · v1.0.0

contamination of the products with common mold