Events

Recall of Device Recall THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE

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

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
    71247
  • Event Risk Class
    Class 2
  • Event Number
    Z-1801-2015
  • Event Initiated Date
    2015-05-12
  • Event Date Posted
    2015-06-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137034
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Reason
    Potential breach in sterility.
  • Action
    Teleflex sent an Urgent Medical Recall Notification dated May 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter directed the customers to quarantine the affected product and return it to the manufacturer. If you have any further questions please call 1-866-246-6990.

Device

Device Recall THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE
  • Model / Serial
    3103376, 3103377, 3103378, 3524557, 3547157, 3693167, 3843307, 3868998, 3986753, 3991994, 3991995, 3999583, 4011996, 4023525, 4040723, 4040724
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : NC, MD, MS, TX and MO., and Internationally to Canada and Denmark.
  • Product Description
    T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation
  • Manufacturer
    Vidacare Corporation

Manufacturer

Vidacare Corporation
  • Manufacturer Address
    Vidacare Corporation, 4350 Lockhill Selma Rd, Suite 150, Shavano Park TX 78249-2162
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA