Events

Recall of Device Recall BLOMSINGER indwelling TEP Occluder

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
    62970
  • Event Risk Class
    Class 3
  • Event Number
    Z-2336-2012
  • Event Initiated Date
    2012-03-08
  • Event Date Posted
    2012-09-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112155
  • 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
    Helix medical llc is recalling the blom-singer indwelling tep occluder due to an invalid expiration date.
  • Action
    A recall letter dated March 8, 2012, was sent to customers who purchased the Blom-Singer Rapid Response Voice Prosthesis TEP Occluder 4mm 20Fr. (IN2004-TO). The letter informed the customers of the problem identified and the action to be taken. Customers were instructed to contact Customer Service Center at (800) 477-5969 if they have products to be returned. Customers were instructed to return Blom-Singer Rapid Response Voice Prosthesis TEP Occluder 4mm 20Fr. (IN2004-TO) to: Helix Medical, LLC Attn to: Customer Service-IN2004-TO. 1110 Mark Avenue Carpinteria, CA 93013 For questions regarding this recall call 805-684-3304.

Device

Device Recall BLOMSINGER indwelling TEP Occluder
  • Model / Serial
    Lot#1008419
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom
  • Product Description
    BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO || The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.
  • Manufacturer
    Helix Medical LLC

Manufacturer

Helix Medical LLC