Events

Recall of 18 gage XTW needles

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Thomas Medical Products 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
    49531
  • Event Risk Class
    Class 2
  • Event Number
    Z-0131-2009
  • Event Initiated Date
    2008-09-12
  • Event Date Posted
    2008-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73741
  • 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
    Introducer needle - Product Code DYB
  • Reason
    Difficulty inserting guidewire through introducer needle. needle hub is not tapered down to the needle cannula.
  • Action
    On 9/11/08, Thomas Medical Products issued letters to the distributors informing them of the problem, to cease distribution and await further instructions. Additional instructions to the distributors were to notify all their account via an advisory notice and request that the user not use the needle supplied with the kit and to replace with another commercially available sterile 18 gage introducer needle.

Device

18 gage XTW needles
  • Model / Serial
    Lot numbers S25589, S25590, S25756, S25769, S25787, S25909, S25910X1, S25911, S25924, S25948, S25949, S25950, S25951, S25972, S25973, S25974, S25975, S25996, S25997, S25998, S26001, S26002, S26003, S26009, S26010, S26011, S26012, S26039,S26040, S26044, S26045, S26058, S26059, S26060, S26063, S26064,S26088, S26089, S26092, S26095, S26102, S26146, S26177, S26178, S26182, S26183, S26198, S26203, S26214, S26217, S26218, S26230, and S26345.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution via distributors in CA, MA, and MN.
  • Product Description
    18 gage XTW needles, sold as a component in SafeSheath Hemostatic Tear-away Introducer System with Infusion Side Port kits or sold Bulk Non Sterile (BNS).
  • Manufacturer
    Thomas Medical Products Inc

Manufacturer

Thomas Medical Products Inc
  • Manufacturer Address
    Thomas Medical Products Inc, 65 Great Valley Pkwy, Malvern PA 19355-1302
  • Source
    USFDA