BEUDAMED
    FDA Recall Terminated

    Bio Med Devices Patient Breathing Circuit Catalog Number: 80015 Labeled in part: DO NOT REUSE DISPOSABLE DISPOSABLE PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT SMOOTH BORE HOSE 1-ADAPTER 22mmx22mm 22mmIDx72'' w/CLIPS 1-ADULT PRESSURE TEE w/.140 HOLE 1-LINE 1/8''IDx84'' 1-TEE 1/8''x1/8''x1/8'' 1-LINE 1/8''IDx24'' 1-HOLDING ARM 1-LINE 1/8''IDx2'' 1-CUFF 1/4''IDx2''

    Recall: Z-0424-05 · Initiated December 6, 2004

    Recall

    Recall Number
    Z-0424-05
    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: 80015 Labeled in part: DO NOT REUSE DISPOSABLE DISPOSABLE PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT SMOOTH BORE HOSE 1-ADAPTER 22mmx22mm 22mmIDx72'' w/CLIPS 1-ADULT PRESSURE TEE w/.140 HOLE 1-LINE 1/8''IDx84'' 1-TEE 1/8''x1/8''x1/8'' 1-LINE 1/8''IDx24'' 1-HOLDING ARM 1-LINE 1/8''IDx2'' 1-CUFF 1/4''IDx2''

    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