FDA Medical Device Recalls (openFDA)
ASO, LLC: 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.
- Recall number
- Z-1892-2013
- Recalling firm
- ASO, LLC
- Product
- 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.
- Status
- Terminated
- Initiated
- 2013-07-26
- Posted
- 2013-08-06
- Terminated
- 2014-08-04
- 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: 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
- 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.
- Lot, serial or model codes
- ASO Packaging Lot #s: 114870, 321860, 386990, 474650, 386990, 223251, 237641, 328481, 228682, and 266542
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MGO
- Firm FEI
- 1038758
- Firm city
- Sarasota
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28