Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient's body. It is also used as a tourniquet to restrict blood flow to a part of a patient's body.
FDA Recall Z-1649-2014 · Posted 2014-05-21
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Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeFQM
Date Initiated2014-03-20
Date Terminated2017-11-29
Product Quantity2,860 bandages
Reason for Recall
This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.
Firm Action
Medline Industries issued an Immediate Action Required letter dated March 20, 2014 to all affected customers. The letters included instructions to: 1) immediately check inventories for the recalled products and quarantine the recalled products; 2) complete and return the enclosed destruction form listing the quantity of destroyed product (credit will only be issued if the completed form is received); and 3) If the customer is a distributor, promptly notify the distributor's customers that may have received the recalled products about this recall. Direct accounts and their customers that have any questions can contact Medline Industries at 866-359-1704.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution including AZ, CA, IA, IL, IN, KY, LA, MI, MS, NJ, NY, OH, PA, TX, and WA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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