BEUDAMED
    FDA Recall Terminated

    Bio Med Devices Patient Breathing Circuit Catalog Number: 80011 Labeled in part: '':PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42'' 1-PRESSURE GAGE LINE 3/16''IDx54'' 1-PATIENT HOSE 22mmIDx24'' 3-ADAPTERS 22mm x 22mm 1-PATIENT HOSE 22mmIDx6'' 1-ADULT PRESSURE TEE 1-EXHALATION VALVE w/HOLDING ARM& 1-TEMPERATURE ADAPTER 22mmID x 22mm COLLECTION HEAD 2-CUFF 1/4''ID x 5/4'' 1-EXHALATION VALVE LINE 1/8''IDx52''

    Recall: Z-0423-05 · Initiated December 6, 2004

    Recall

    Recall Number
    Z-0423-05
    Event Number
    30580
    Firm
    Bio-Med Devices, Inc.
    FEI Number
    3003952420
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 6, 2004
    Posted
    January 29, 2005
    Terminated
    November 21, 2005
    Address
    1445 Boston Post Road, Guilford, CT, 06437-4338

    Description

    Bio Med Devices Patient Breathing Circuit Catalog Number: 80011 Labeled in part: '':PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42'' 1-PRESSURE GAGE LINE 3/16''IDx54'' 1-PATIENT HOSE 22mmIDx24'' 3-ADAPTERS 22mm x 22mm 1-PATIENT HOSE 22mmIDx6'' 1-ADULT PRESSURE TEE 1-EXHALATION VALVE w/HOLDING ARM& 1-TEMPERATURE ADAPTER 22mmID x 22mm COLLECTION HEAD 2-CUFF 1/4''ID x 5/4'' 1-EXHALATION VALVE LINE 1/8''IDx52''

    Reason

    Adapters may be occluded potentially preventing inhalation

    Action

    Bio-Med Devices issued recall notifcation by fax on 12/7/04. Accounts are requested to discontine use and return product. A Press Release issued to AP 12/8/04

    Distribution

    Nationwide Forign: Canada, Greece, Japna, Israel, Saudi Arabia,

    Quantity

    159 cs