BEUDAMED
    FDA Recall Terminated

    Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA

    Recall: Z-1692-2008 · Initiated March 21, 2008

    Recall

    Recall Number
    Z-1692-2008
    Event Number
    47523
    Firm
    Covidien Limited
    FEI Number
    2936999
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 21, 2008
    Posted
    September 16, 2008
    Terminated
    October 29, 2008
    Address
    6135 Gunbarrel Ave, Boulder, CO, 80301-3214

    Description

    Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA

    Reason

    Wiring in battery back-up power supply may short and cause thermal damage to ventilator.

    Action

    All customers were notified by Federal Express letter and were contacted by phone through field service engineers. They were told to examine their inventory for any installed or spare part battery assemblies and to remove and quarantine these parts. Any ventilators with installed affected battery assemblies were to be taken out of service.

    Distribution

    Nationwide, including one VA facility in IL and two military facilities in NC and NY. No foreign distribution.

    Quantity

    6 Ventilators and 151 factory replacement units