BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2336-2012 · Initiated March 8, 2012

    Recall

    Recall Number
    Z-2336-2012
    Event Number
    62970
    Firm
    Helix Medical LLC
    FEI Number
    2025182
    Product Code
    EWL
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    March 8, 2012
    Posted
    September 7, 2012
    Terminated
    April 2, 2013
    Address
    1110 Mark Ave, Carpinteria, CA, 93013-2918

    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.

    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.

    Distribution

    Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom

    Quantity

    2 devices