Recall Z-1074-2017— Medline Industries Inc
Class II · Terminated
Class II FDA medical device recall by Medline Industries Inc, initiated 2016-11-23, terminated 2019-07-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds. Reason: 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)...
- Recalling firm
- Medline Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-23
- Terminated
- 2019-07-19
- Firm location
- Mundelein, IL, United States
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)..
Data sourced from openFDA. This site is unofficial and independent of the FDA.