Events

Recall of Device Recall Galt Valved Tearaway Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Galt Medical 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
    68939
  • Event Risk Class
    Class 2
  • Event Number
    Z-2589-2014
  • Event Initiated Date
    2014-07-25
  • Event Date Posted
    2014-09-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129056
  • 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, catheter - Product Code DYB
  • Reason
    The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
  • Action
    Galt Medical sent an Urgent Medical Device Recall letters to all affected customers. The letter identified the affected product, reason for recall and actions to be taken. Customers were asked to identify and segregate the recalled lot (s) that is in their possession, complete and return the enclosed Recall Reply form, and return the recalled product to Galt Medical Corp. For questions contact your local sales representative or Recall Coordinator at 214-778-1306.

Device

Device Recall Galt Valved Tearaway Kit
  • Model / Serial
    Catalot Numbers: KIT-043-06, KIT-043-07, KIT-043-08, KIT-043-09, KIT-043-10, KIT-043-11, KIT-053-06, KIT-053-07, KIT-053-08, KIT-053-09, KIT-053-10, KIT-053-11, KIT-053-12, KIT-053-17, KIT-053-18, KIT-053-19, KIT-053-20, KIT-053-21, and KIT-053-22
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece.
  • Product Description
    GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO || Product Usage: || Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
  • Manufacturer
    Galt Medical Corporation

Manufacturer

Galt Medical Corporation
  • Manufacturer Address
    Galt Medical Corporation, 2220 Merritt Dr, Garland TX 75041-6137
  • Manufacturer Parent Company (2017)
    Juniper Holdings Inc.
  • Source
    USFDA