Events

Recall of Device Recall Angiomat Illumena Syringe, 150mL Linden Luer Syringe with HandiFil Straw (p/n 900103)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mallinckrodt 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
    59103
  • Event Risk Class
    Class 2
  • Event Number
    Z-2859-2011
  • Event Initiated Date
    2011-05-20
  • Event Date Posted
    2011-07-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101150
  • 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
    Injection, contrast medium, automatic - Product Code IZQ
  • Reason
    Syringes packaged and labeled as the illumena 150ml linden luer syringe with handi-fil straw, product 900103, contained the illumena150ml syringe with handi-fil straw, product 900101.
  • Action
    COVIDIEN sent an Urgent Device Recall letter dated May 20, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use the attached business response form and report the quantity of lot number 0253304 currently in their stock. If the customer did not have any of the affected lot they were to indicate by checking the appropriate box on the form. When completed, customers were asked to fax to (314) 654-8206 or email to productmonitoringhazelwood@covidien.com. All product from lot number 0253304 was to be returned to Covidien. Once the business notification form is received a Return Goods Authorization for the quantity of product reported will be sent to the customer. Customers would receive credit for all return product from affected lot. For any questions regarding this recall customers were asked to contact the Product Monitoring department at 800-778-7898. For questions about credit for the product, call Customer Service at 888-744-1414, menu option 1, and then menu option 2.

Device

Device Recall Angiomat Illumena Syringe, 150mL Linden Luer Syringe with HandiFil Straw (p/n 900103)
  • Model / Serial
    Lot number - 0253304, Part No. 900103
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, FL, IL, IN, MI, MO, NY, OH, TN & TX. and the country of Australia.
  • Product Description
    Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded plastic tray. || The Liebel Flarsheim Illumena 150 mL Linden Luer Syringe with Handi-Fil Straw is designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals.
  • Manufacturer
    Mallinckrodt Inc

Manufacturer

Mallinckrodt Inc
  • Manufacturer Address
    Mallinckrodt Inc, 2111 E Galbraith Rd, Cincinnati OH 45237-1624
  • Source
    USFDA