Events

Recall of Stellant Syringe Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medrad 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
    30240
  • Event Risk Class
    Class 2
  • Event Number
    Z-0039-05
  • Event Initiated Date
    2004-10-08
  • Event Date Posted
    2004-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35543
  • 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
    Injector And Syringe, Angiographic - Product Code DXT
  • Reason
    Sterility can be compromised by a component tearing the outer packaging.
  • Action
    The recalling firm telephoned their customers on 10/8/04 to inform them of the problem and the need to return the product.

Device

Stellant Syringe Kit
  • Model / Serial
    Lot number 45535 exp 9/2008
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities in AR, CA, CO, FL, LA, MI, NJ, NY, PA, and TX.
  • Product Description
    Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
  • Manufacturer
    Medrad Inc

Manufacturer

Medrad Inc
  • Manufacturer Address
    Medrad Inc, 1 Medrad Dr, Indianola PA 15051-9759
  • Source
    USFDA