BEUDAMED
    FDA Recall Terminated

    Pneumotach, Disposable (B) Catalog Number: 4408 Labeled in part: SINGLE USE CATALOG NO.4408 PNEUMOTACH, DISPOSABLE (B) =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1- PNEUMOTACH HEAD ASSEMBLY 1- PARATUBE 60'' 2- TUBING FITTINGS 1- 22x22mm ADAPTER

    Recall: Z-0428-05 · Initiated December 6, 2004

    Recall

    Recall Number
    Z-0428-05
    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

    Pneumotach, Disposable (B) Catalog Number: 4408 Labeled in part: SINGLE USE CATALOG NO.4408 PNEUMOTACH, DISPOSABLE (B) =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1- PNEUMOTACH HEAD ASSEMBLY 1- PARATUBE 60'' 2- TUBING FITTINGS 1- 22x22mm ADAPTER

    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

    107 cs