Events

Recall of Device Recall Leader Wound Closure Adhesive Surgical Tape Strips

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ASO, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65819
  • Event Risk Class
    Class 2
  • Event Number
    Z-1892-2013
  • Event Initiated Date
    2013-07-26
  • Event Date Posted
    2013-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120301
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Closure, Wound, Adhesive - Product Code MGO
  • Reason
    This recall has been initiated by aspen surgical products, inc., due to the inability to confirm sterility.
  • 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.

Device

Device Recall Leader Wound Closure Adhesive Surgical Tape Strips
  • Model / Serial
    ASO Packaging Lot #s: 114870, 321860, 386990, 474650, 386990, 223251, 237641, 328481, 228682, and 266542
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.
  • Product Description
    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.
  • Manufacturer
    ASO, LLC

Manufacturer

ASO, LLC
  • Manufacturer Address
    ASO, LLC, 300 Sarasota Center Blvd, Sarasota FL 34240-9381
  • Manufacturer Parent Company (2017)
    Aso Corporation
  • Source
    USFDA