Events

Recall of Device Recall MassTRANSIT Infusion Catheter Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cordis 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
    50154
  • Event Risk Class
    Class 2
  • Event Number
    Z-0604-2009
  • Event Initiated Date
    2008-06-30
  • Event Date Posted
    2008-12-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-01-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74869
  • 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
    Continuous Flush Catheter - Product Code KRA
  • Reason
    Two lots of cordis neurovascular masstransit infusion catheter kits has the potential for sterile ptfe contamination within the inner lumen of the catheter.
  • Action
    A Medical Device Recall letter, dated 6/30/2008, and Acknowledgement Form were sent overnight. The firm asked customers to set aside any affected product in a manner that ensures it will not be used. Customers are asked to review, sign and return the enclosed Acknowledgement Form directly to Cordis Neurovascular. Customers can either return any product with reference to the RA# on the form, or contact their local sales reps to facilitate return of the affected product. Customers will receive a credit for the units they return. If any affected product has been forwarded to another facility, the facility should be contacted to arrange return of the product. If there are any additional questions, Customer Service may be also be contacted at 800-551-7683.

Device

Device Recall MassTRANSIT Infusion Catheter Kit
  • Model / Serial
    Lot Number 13358689 and 13350390.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of Colorado, Connecticut, Florida, Minnesota, Nebraska, Nevada, Ohio, Oregon, and Virginia.
  • Product Description
    MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular || Intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the Neurovascular, Peripheral Vascular and Coronary Vascular systems and for superselective angiography of peripheral and coronary vasculature.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Manufacturer Address
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA