Events

Recall of Device Recall Kendall

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tyco Healthcare/Kendall.

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
    25817
  • Event Risk Class
    Class 2
  • Event Number
    Z-0743-03
  • Event Initiated Date
    2003-03-20
  • Event Date Posted
    2003-04-18
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26525
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Tandem hemodialysis catheter may have splits in the catheter shaft below the extension adapter.
  • Action
    The firm notified accounts by letter on 3/20/03 by overnight mail delivery. Users are requested to examine, remove and return product.

Device

Device Recall Kendall
  • Model / Serial
    All lots
  • Product Classification
    Gastroenterology-Urology Devices
  • Distribution
    Nationwide International: Canada, Chile, Singapore. Belgium
  • Product Description
    Tandem-Cath Hemodialysis Cuffed Catheter with no side holes || 10 Fr 28 cm Arterial Cuff/31cm Venous Cuff || Code #: 8888-228310
  • Manufacturer
    Tyco Healthcare/Kendall

Manufacturer

Tyco Healthcare/Kendall
  • Manufacturer Address
    Tyco Healthcare/Kendall, 15 Hampshire Street, Mansfield MA 02048
  • Source
    USFDA