Events

Recall of Device Recall BlomSinger Adjustable Tracheostoma Valve II

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Helix Medical LLC.

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
    66423
  • Event Risk Class
    Class 3
  • Event Number
    Z-0128-2014
  • Event Initiated Date
    2013-10-01
  • Event Date Posted
    2013-11-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122369
  • 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
    Prosthesis, laryngeal (taub) - Product Code EWL
  • Reason
    Inhealth technologies (iht) is recalling the blom-singer adjustable tracheostoma valve ii (atsv ii) because the body component of the device is missing from the packaging. the atsv ii valve product cannot be used as intended without the product body.
  • Action
    A phone script and a customer notification letter are provided. The recall was initiated on 10/1/13 and customers will be notified that InHealth Technologies, a division of Helix Medical, LLC has initiated a recall of the following 3 lots of the Blom-Singer Adjustable Tracheostoma Valve (BE8025H and BE8025H-R3): 1057760, 1057919 and 1059222. The phone script provides the problem identified and the actions to be taken. Customers are instructed to complete the Customer response form and return by email to belinda.jackson@helixmedical.com, fax to (805) 566-5381 or by mail to InHealth Technologies, 1110 Mark Avenue, Carpinteria, CA 93013. Customers are also instructed to Contact UPS at 1-800-742-5877 and provide In Health Technologies UPS account no., 846718. UPS will come to your site, package the recalled product(s) and ship it to InHealth Technologies at InHealth Technologies expense. Customers are instructed to respond within 10 days.

Device

Device Recall BlomSinger Adjustable Tracheostoma Valve II
  • Model / Serial
    LOTS: 1057760, 1057919 and 1059222
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.
  • Product Description
    Blom-Singer Adjustable Tracheostoma Valve II || Models: BE8025H and BE8025H-R3
  • Manufacturer
    Helix Medical LLC

Manufacturer

Helix Medical LLC