Z-1074-2017 Class II Terminated
FDA device recall Z-1074-2017 was initiated by Medline Industries Inc on Nov 23, 2016 and is designated Class II. Reason for recall: Medline Industries, Inc is recalling Unna Z Unna Boot Bandage 3 X10 and Unna Z Unna Boot Bandage 4 X10 due to contamination of the products with common mold (Cladosporium… The recall status is terminated (terminated Jul 19, 2019). Affected quantity: 117,059 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 1, 2017
- Initiation Date
- Nov 23, 2016
- Termination Date
- Jul 19, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 117,059 units
Product Description
Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds
Reason for Recall
Medline Industries, Inc is recalling Unna Z Unna Boot Bandage 3 X10 and Unna Z Unna Boot Bandage 4 X10 due to contamination of the products with common mold (Cladosporium sphaerospermum/cladosporioides/herbarum/phaenocomae/halotolerans and Penicillium corylophilum)..
Distribution Pattern
Worldwide Distribution - USA (nationwide) and to the countries of : Chile, Peru, El Salvador and Taiwan.
Code Information
Unit Numbers: NONUNNA3 & NONUNNA4 Lot Numbers: 52581 through 63599
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1074-2017
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026