BEUDAMED
    FDA Recall Terminated

    Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890

    Recall: Z-0961-05 · Initiated June 7, 2005

    Recall

    Recall Number
    Z-0961-05
    Event Number
    32297
    Firm
    Smiths Medical International Ltd Reachfields Boundry Road Hythe United Kingdom
    FEI Number
    3002807908
    Product Code
    CAH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 7, 2005
    Posted
    July 7, 2005
    Terminated
    May 8, 2012

    Description

    Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890

    Reason

    Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label

    Action

    Smiths Medical notified 8 accounts by letter dated June 3, 2005. Distributors are requested to contact accounts end-users (hospitals) . Users are requested to return inventory.

    Distribution

    CA, NJ, PA, WV

    Quantity

    292 units