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U.S. Department of Health and Human Services

Class 2 Device Recall Premier Value Wound Closure Adhesive Surgical Tape Strips

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  Class 2 Device Recall Premier Value Wound Closure Adhesive Surgical Tape Strips see related information
Date Initiated by Firm July 26, 2013
Date Posted August 06, 2013
Recall Status1 Terminated 3 on August 04, 2014
Recall Number Z-1894-2013
Recall Event ID 65819
Product Classification Closure, Wound, Adhesive - Product Code MGO
Product Premier Value Wound Closure Adhesive Surgical Tape Strips
30 strips 1/4 in. x 4 in. Sterile latex free

UPC # 040986021558

Used to secure, close and support small cuts and wounds.
Code Information ASO Packaging Lot#s: 218620, 354840, 546660, 115451, 223771, 285451, 324201, 366061, 193702, 227822, 263592, 302572, 123313, 123293, 123303 123313, 123283, and 28955  
Recalling Firm/
Manufacturer		 ASO, LLC
300 Sarasota Center Blvd
Sarasota FL 34240-9381
For Additional Information Contact Michelle Pulaski
888-364-7004 Ext. 146
Manufacturer Reason
for Recall		 This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.
FDA Determined
Cause 2		 Package design/selection
Action ASO sent a letter on July 26, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine your inventory and stop using/distributing the product. Place in quarantine to be returned or destroyed. ASO customers will receive credit for returned product or a returned completed Certificate of Destruction. Please use Return Authorization Number 1675 when returning the product. Please complete and return the enclosed response form as soon as possible. Return the form to: Address: ASO LLC Regulatory Affairs 300 Sarasota Center Blvd. Sarasota, FL 34240 Fax: 941-378-9040 Attn: Regulatory Affairs For questions regarding this recall call 888-364-7004, ext 146.
Quantity in Commerce Total 2,689,560 pouches (2 cards/pouch)
Distribution Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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