Events

Recall of Device Recall none

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

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
    54680
  • Event Risk Class
    Class 2
  • Event Number
    Z-1592-2010
  • Event Initiated Date
    2010-02-08
  • Event Date Posted
    2010-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89001
  • 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
    Vessel Dilator for Percutaneous Catheterization - Product Code DRE
  • Reason
    Potential problem with pouch seal thus affecting sterile product.
  • Action
    Firm notified distributor by telephone 2/8/2010. Firm and distributor partnered to notify customers by an Urgent: Medical Device Recall - Lot Specific letter, dated 2/10/2010, beginning 2/16/2010. The letter identified the affected product and the reason for the recall. The letter asked customers to immediately check their inventory remove any affected kits and place them in a secure location. Customers are to complete the Product Recall Inventory Form and fax it to the Customer Service Department. Customers are also to contact Customer Service for a Return Authorization Number at 1-866-240-6001. Affected products will be replaced upon receipt. Questions or concerns should be directed to a local Sales Representative or Jill Eisenzimmer, Product Manager, at 763-656-4300.

Device

Device Recall none
  • Model / Serial
    Lot F0620209
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- MI, PA, IL, & Washington, D.C.
  • Product Description
    Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464 Sycamore Court, Minneapolis, MN 53369.
  • Manufacturer
    Galt Medical Corp

Manufacturer

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