Events

Recall of Device Recall Jet Ventilation Catheter (transtracheal)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by VBM Medical 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
    58807
  • Event Risk Class
    Class 2
  • Event Number
    Z-2675-2011
  • Event Initiated Date
    2011-05-09
  • Event Date Posted
    2011-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100369
  • 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
    Tube, tracheostomy (w/wo connector) - Product Code BTO
  • Reason
    Product labeled with incorrectly as being appropriate for use in adults when the intended population for use of the product is children and infants.
  • Action
    VBM Medical Inc sent an "URGENT FIELD SAFETY NOTICE" dated May 9, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The reference and lot numbers, details of the error, along with the incorrect and correct box label, and instructions to the customers to discard the box with the incorrect label or send the complete product back to VBM Medical Inc. for re-packaging. For any further or detailed questions, please contact VBM Medical Inc. at (317) 776-1800. On 7/12/11 upon receiving the recall classification letter, the firm sent out an additional letter to its direct accounts informing them of the recall's classification and reiterating the instructions listed above.

Device

Device Recall Jet Ventilation Catheter (transtracheal)
  • Model / Serial
    Lot numbers 28327, 30067, 31065, 32642 and article number ACU 1060.2
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA ( nationwide ) including the country Montreal QC
  • Product Description
    Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-914-1, VBM Medizintechnik GmbH, Einsteinstrasse 1 7212 Sulz a.N. Germany || Allows a safe and atraumatic transtracheal access for oxygenation/ventilation with a manual jet ventilator or an automatic high frequency jet ventilator.
  • Manufacturer
    VBM Medical Inc.

Manufacturer

VBM Medical Inc.
  • Manufacturer Address
    VBM Medical Inc., 524 Herriman Ct, Noblesville IN 46060-4363
  • Manufacturer Parent Company (2017)
    VBM Medical Inc.
  • Source
    USFDA