BEUDAMED
    FDA Recall Terminated

    Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20

    Recall: Z-1431-06 · Initiated July 12, 2006

    Recall

    Recall Number
    Z-1431-06
    Event Number
    35879
    Firm
    Nellcor Puritan Bennett
    FEI Number
    2936999
    Product Code
    BSR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 12, 2006
    Posted
    August 24, 2006
    Terminated
    January 10, 2007
    Address
    4280 Hacienda Dr, Pleasanton, CA, 94588-2719

    Description

    Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20

    Reason

    Product's outer sheath material may separate from the wire interior during use and may lodge in the endotracheal tube or enter the patient's airway and interfere with ventilation.

    Action

    The firm has issued notification letters via USPS certified mail with return receipt, requesting that the recipients who have further distributed the product forward a copy of that letter. The firm intends to contact non-responding companies beginning 30 days after the initial notification is sent.

    Distribution

    The product has been distributed to 454 consignees throughout the United States, Guam and Japan.

    Quantity

    30,366 cases of 20 units per case were distributed worldwide