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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description 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.
Recall Number Z-1649-2014
Classification Class II
Code Info Product Number: DYNJ05116A . Lot Number: 13LA1009.
Product Distributed Qty 2,860 bandages
Reason For Recall This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.

Event Detail

Event Id 67858
Product Type Devices
Status Ongoing
Recalling Firm Medline Industries Inc
City Mundelein
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including AZ, CA, IA, IL, IN, KY, LA, MI, MS, NJ, NY, OH, PA, TX, and WA.