Recall Z-1895-2013 ยท MGO Closure, Wound, Adhesive
ASO, LLC
TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 036800165854 Used to secure, close and support small cuts and wounds.
| Date | Aug 6, 2013 (initiated Jul 26, 2013) |
| Status | Terminated |
| Reason | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. |
| Root cause | 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: AS |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.