| Class 2 Device Recall Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips | |
Date Initiated by Firm | July 26, 2013 |
Date Posted | August 06, 2013 |
Recall Status1 |
Terminated 3 on August 04, 2014 |
Recall Number | Z-1889-2013 |
Recall Event ID |
65819 |
Product Classification |
Closure, Wound, Adhesive - Product Code MGO
|
Product | Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips
30 strips 1/4 in. x 4 in. Sterile latex free
UPC # 093351120374
Used to secure, close and support small cuts and wounds. |
Code Information |
ASO Packaging Lot #: 208351 |
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.
|
|
|
|