Events

Recall of Device Recall TAUT, Cholangiogram Catheter Intraducer

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
    62598
  • Event Risk Class
    Class 3
  • Event Number
    Z-2186-2012
  • Event Initiated Date
    2012-07-20
  • Event Date Posted
    2012-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111121
  • 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
    Catheter, peritoneal - Product Code GBW
  • Reason
    Product is missing the label on the internal packaging.
  • Action
    Consignees were notified by letter on 07/20/2012

Device

Device Recall TAUT, Cholangiogram Catheter Intraducer
  • Model / Serial
    Catalog number: PI-128, Lot number: 01C200424, 01C1200425 and 01C1200426.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MI, MO, MS, NC, NY, OH, PA, SD, TX, UT, VA, WI, WV.
  • Product Description
    TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. || An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr., Research Triangle Park NC 27709
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA