BEUDAMED
    FDA Recall Terminated

    Drger Medical, REF 40314160, Bird-Bennet-Monaghan IPPB circuit, Latex Free, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico

    Recall: Z-0293-05 · Initiated December 2, 2004

    Recall

    Recall Number
    Z-0293-05
    Event Number
    30526
    Firm
    Unomedical, Inc
    FEI Number
    1000160240
    Product Code
    BZA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 2, 2004
    Posted
    December 8, 2004
    Terminated
    September 7, 2006
    Address
    6001 S 35th St, Mcallen, TX, 78503-8887

    Description

    Drger Medical, REF 40314160, Bird-Bennet-Monaghan IPPB circuit, Latex Free, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico

    Reason

    Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation

    Action

    The firm issued a Public Safety Alert on 11/30/2004. The firm expanded their safety alert on 12/02/2004 and issued press informing of a recall. The firm sent recall letters to consignees on 12/02/2004.

    Distribution

    The product was distributed nationwide to hospitals, home healthcare, and medical transport. Distribution to foreign countries included: Canada; Russia; France; Switzerland; Argentina; Uruguay; and Mexico

    Quantity

    24 cases; 50 units/case (1,200 units total)