Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 096295114706 Used

FDA device recall Z-1892-2013 · posted 2013-08-06 · Terminated

Recall details

Recalling firm

ASO, LLC

Reason for recall

This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.

Action taken

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

Status

Terminated

Product code

MGO

Quantity affected

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.

Date initiated

2013-07-26

Date posted

2013-08-06

Date terminated

2014-08-04

Location

Sarasota, FL