Events

Recall of Device Recall 2010 Video Guided Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Myelotec, 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
    77508
  • Event Risk Class
    Class 2
  • Event Number
    Z-2779-2017
  • Event Initiated Date
    2017-03-02
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156176
  • 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
    Arthroscope - Product Code HRX
  • Reason
    Obstructed/blocked port from defective vgc access port body component.
  • Action
    Myelotec sent an Urgent Product Recall Notification letter dated April 10, 2017, to all affected customers. Customers are instructed to notify customers of any product further distributed, identify any recalled product on hand, and to complete the attached recall response, to be sent back to the distributor. For further questions, please call (770) 664-4656 Ext. 140.

Device

Device Recall 2010 Video Guided Catheter
  • Model / Serial
    Lot No. 4123/MY33613, 4250/MY06614, 4279/MY06614, 4305/MY10814, 4331/MY13914, and 4331/MY25214
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : CA, FL, KY, MN, and NJ ., and to the countries of : Brazil, Iran, Kuwait, Malaysia, Singapore, South Korea, Taiwan, and Turkey
  • Product Description
    Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
  • Manufacturer
    Myelotec, Inc.

Manufacturer

Myelotec, Inc.
  • Manufacturer Address
    Myelotec, Inc., 4000 Northfield Way Ste 900, Roswell GA 30076-4955
  • Manufacturer Parent Company (2017)
    Myelotec Inc.
  • Source
    USFDA