RecallDepth

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.

Company
Medline Industries Inc
Recall Initiated
March 20, 2014
Posted
May 21, 2014
Terminated
November 29, 2017
Recall Number
Z-1649-2014
Quantity
2,860 bandages
Firm Location
Mundelein, IL

Reason for Recall

This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.

Distribution

Nationwide Distribution including AZ, CA, IA, IL, IN, KY, LA, MI, MS, NJ, NY, OH, PA, TX, and WA.

Lot / Code Info

Product Number: DYNJ05116A .  Lot Number: 13LA1009.

Root Cause

Employee error

Action Taken

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.

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