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.
FDA Recall Z-1892-2013 · Posted 2013-08-06
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Recalling FirmASO, LLC
Recall StatusTerminated
Product CodeMGO
Date Initiated2013-07-26
Date Terminated2014-08-04
Product QuantityTotal 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.
Firm 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.
Root Cause
Package design/selection
Distribution Pattern
Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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