Events

Recall of Device Recall TissueLink

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

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
    29697
  • Event Risk Class
    Class 2
  • Event Number
    Z-1416-04
  • Event Initiated Date
    2004-07-22
  • Event Date Posted
    2004-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34390
  • 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
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • Reason
    Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the adp housing.
  • Action
    TissueLink notified the sales force on 7/22/04 to visit each account and retreive product at the hospital level.

Device

Device Recall TissueLink
  • Model / Serial
    Lot Numbers: TLK17300, TLB02400
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    ADP 3.2 Adapter, non sterile reusable || Model Number: 30-801-1, an accessory used with the TissueLink Bipolar Floating Device
  • Manufacturer
    TissueLink Medical, Inc.

Manufacturer

TissueLink Medical, Inc.
  • Manufacturer Address
    TissueLink Medical, Inc., One Washington Center, Suite 400, Dover NH 03820
  • Source
    USFDA