Events

Recall of Device Recall Myelotec Steerable 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
    46317
  • Event Risk Class
    Class 2
  • Event Number
    Z-0586-2008
  • Event Initiated Date
    2007-12-19
  • Event Date Posted
    2008-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67177
  • 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
    Incorrect labeling information: product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation.
  • Action
    Consignees were first notified by phone on 12/19/2007. A follow up Urgent Label Insert Recall Notification letter was sent via certified mail on/about 12/28/2007. Consignees were instructed to remove the subject label inserts from the affected product in inventory, replace with the enclosed revised label inserts and to complete the attached Recall and Accountability Form. The incorrect label inserts were to be returned, via package provided to Myelotec.

Device

Device Recall Myelotec Steerable Video Guided Catheter
  • Model / Serial
    Label Inserts: LB0013-1, LB0013-2, and LB0013-3.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AL, CA, CT, FL, GA, ID, IN, ME, MN, NH, NJ, NY, OH, and OR, and countries of Aurba, Korea, Japan, Switzerland, South Africa, UK.
  • Product Description
    Myelotec¿ Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and LB0013-3. (product code: 2000) Myelotech, Roswell, GA 30076.
  • Manufacturer
    Myelotec, Inc.

Manufacturer

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