Events

Recall of Device Recall TAUT ADAPt

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

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
    55676
  • Event Risk Class
    Class 2
  • Event Number
    Z-1890-2010
  • Event Initiated Date
    2010-05-12
  • Event Date Posted
    2010-06-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91531
  • 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
    laparoscope, general & plastic surgery - Product Code GCJ
  • Reason
    Balloon does not hold air or water once inflated.
  • Action
    The firm, Teleflex Medical, sent an "Urgent Medical Device Recall" letter dated May 10, 2010 to customers The letter described the product, problem and action to be taken by the customers. They were instructed to return all of the affected product to Teleflex. Each distributor was instructed to forward the letter to their customers to retrieve relevant product from those locations. A second mailing to non-responding customers will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, email, or fax. A record of these contacts will be maintained. Affected products received by Teleflex Medical will be destroyed upon receipt. Records will be maintained accordingly. Teleflex Medical will communicate to FDA on the status of recall activities. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall TAUT ADAPt
  • Model / Serial
    Catalog Number: 41244, Serial/Lot number: 01E0900215
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of AR, CO, FL, GA, IL, IN, KY, MI, MN, MO, NC, NY, OR, PA, WI, WV and country of France.
  • Product Description
    TAUT ADAPt Balloon Open Access Port And Syringe 10/12mm x 100mm, REF 41244, Rx Only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. || Intended use: The ADAPt Balloon Open Access Port is indicated for the use in thoracic, abdominal and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices. This a single use device, provided sterile.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA