BEUDAMED
    FDA Recall Terminated

    Pedi-Cap CO2 Detector, 1 kg - 15 kg, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. Sold in packages of 6 (PediCap6) or 24 (PediCap). Intended for use during endotracheal or nasotracheal intubation to assist in verification of tube placement.

    Recall: Z-2047-2009 · Initiated August 14, 2009

    Recall

    Recall Number
    Z-2047-2009
    Event Number
    52927
    Firm
    Covidien Limited
    FEI Number
    2936999
    Product Code
    CCK
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    August 14, 2009
    Posted
    September 8, 2009
    Terminated
    June 1, 2012
    Address
    6135 Gunbarrel Ave, Boulder, CO, 80301-3214

    Description

    Pedi-Cap CO2 Detector, 1 kg - 15 kg, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. Sold in packages of 6 (PediCap6) or 24 (PediCap). Intended for use during endotracheal or nasotracheal intubation to assist in verification of tube placement.

    Reason

    CO2 detector may increase resistance to air flow in an intubated patient.

    Action

    Covidien issued an Urgent Medical Device Recall letter dated August 14, 2009 informing Consignees of the affected devices. Users were told to stop use and arrange for return of all affected product. For further information, contact Covidien at 1-800-635-5267.

    Distribution

    Worldwide Distribution -- US (FL, ID, MD, NC, VA and PA including Puerto Rico), Australia, Belgium, Canada, Japan, Singapore.

    Quantity

    276,390 units