Events

Recall of StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Venetec Intl 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
    26365
  • Event Risk Class
    Class 2
  • Event Number
    Z-0925-03
  • Event Initiated Date
    2003-05-12
  • Event Date Posted
    2003-06-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-10-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27569
  • 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
    Set, Administration, Intravascular - Product Code FPA
  • Reason
    Set tubing disconnected from the male luer lock during use on patients. misassembled.
  • Action
    A recall letter was sent to the distributor who then sent thier own letters to the affected hospitals. Hospitals were reached on or about May 14, 2003 whereas the distributor was contacted by telephone and letter on or about May 12, 2003. It was verbally agreed that the distributor would subrecall the product.

Device

StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model n...
  • Model / Serial
    Lot D207201
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    One distributor sent the product to 6 hospitals in the states of CT, IN, PA, TN.
  • Product Description
    StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K.
  • Manufacturer
    Venetec Intl Inc

Manufacturer

Venetec Intl Inc
  • Manufacturer Address
    Venetec Intl Inc, 12555 High Bluff Dr Ste 170, San Diego CA 92130
  • Source
    USFDA