Recall Z-1074-2017 ยท FQM Bandage, Elastic
Medline Industries Inc
Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds
| Date | Nov 23, 2016 |
| Status | Terminated |
| 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).. |
| Root cause | Environmental control |
| Action | 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. |
| Quantity | 117,059 units |
| Distribution | Worldwide Distribution - USA (nationwide) and to the countries of : Chile, Peru, El Salvador and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.