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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

Product Description Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 096295114706 Used to secure, close and support small cuts and wounds.
Recall Number Z-1892-2013
Classification Class II
Code Info ASO Packaging Lot #s: 114870, 321860, 386990, 474650, 386990, 223251, 237641, 328481, 228682, and 266542
Product Distributed Qty Total 2,689,560 pouches (2 cards/pouch)
Reason For Recall This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.

Event Detail

Event Id 65819
Product Type Devices
Status Ongoing
Recalling Firm ASO, LLC
City Sarasota
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.
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