BEUDAMED
    FDA Enforcement Class I Terminated

    Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.

    Recall: Z-1951-2015 · Reported July 15, 2015

    Enforcement

    Recall Number
    Z-1951-2015
    Event ID
    71197
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LP (formerly Nellcor Puritan Bennett Inc.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2015
    Initiation Date
    May 8, 2015
    Classification Date
    July 9, 2015
    Termination Date
    April 12, 2017
    Address
    6135 Gunbarrel Ave, N/A, Boulder, CO, 80301-3214, United States

    Description

    Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.

    Reason

    Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.

    Code Info

    All products manufactured since 2/2012.

    Distribution

    Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.

    Quantity

    69,461 units total