Events

Recall of Device Recall MEDRAD Sterile Disposable 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
    51495
  • Event Risk Class
    Class 2
  • Event Number
    Z-1228-2009
  • Event Initiated Date
    2009-01-29
  • Event Date Posted
    2009-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80546
  • 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
    amgiographic syringe - Product Code DXT
  • Reason
    Possible compromised sterility due to holes in styrene tray.
  • Action
    On 1/29/09, Medrad issued an Urgent Medical Device Recall letter. Customers were requested to check their inventory for any of the affected batch. If the customer has affected product, they are instructed to contact the firm to make arrangement for the return of the product. Non responders were sent additional notifications via FedEx on 3/2/09 and 4/1/09.

Device

Device Recall MEDRAD Sterile Disposable Syringe Kit
  • Model / Serial
    catalog number DSK 130-Q. Lot number 72372
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide: AL, AZ, CA, FL, IL, LA, MA, MT, NC, NY, OH, TX, and WI.
  • Product Description
    MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media.
  • Manufacturer
    Medrad Inc

Manufacturer

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