BEUDAMED
    FDA Recall Terminated

    Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.

    Recall: Z-1465-2017 · Initiated February 9, 2017

    Recall

    Recall Number
    Z-1465-2017
    Event Number
    76433
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    JOH
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    February 9, 2017
    Terminated
    June 20, 2018
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.

    Reason

    Smiths Medical became aware that one lot of the Bivona 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly labeled for pediatric use.

    Action

    Consignees were sent a Smiths Medical "Urgent Medical Device Field Safety Notice" dated February 08, 2017. The letter was addressed to "Clinician". The letter listed the Affected devices, Reason for Recall, Risk to Health, and Instructions to Customers. Advised customers to complete and return the "Urgent Medical Device Field Safety Notice (FSN) Response Form" to [email protected]. All affected devices must be returned to Stericycle for processing. If the product was further distributed, consignees were asked to immediately notify them of the Recall and retrieve all affected devices. For questions contact Stericycle via e-mail at the following address: [email protected].

    Distribution

    US: CA, ILM NC, GA, NE, MA, CO, CT, MO, TN, LA, MD, MN, FL, SC,M OK, MI, PA, TX, WA, WI.

    Quantity

    142