BEUDAMED
    FDA Recall Terminated

    Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI.

    Recall: Z-1032-04 · Initiated May 20, 2004

    Recall

    Recall Number
    Z-1032-04
    Event Number
    29228
    Firm
    Sechrist Industries Inc
    FEI Number
    2020676
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 20, 2004
    Posted
    July 20, 2004
    Terminated
    March 14, 2006
    Address
    4225 E La Palma Ave, Anaheim, CA, 92807-1815

    Description

    Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI.

    Reason

    Electronic manometer malfunctions. Manometer may be illegible. The alarm for power failure may function only briefly, or not at all.

    Action

    Recall notification contains a test method to be used to identify defective units. Return notification that ventilator is defective will result in replacement of the electronic manometer.

    Distribution

    Nationwide and to Malaysia, Japan, Kuwait, Sri Lanka, South Africa, Guatemala, Mexico, Morocco, Indonesia, Korea, Ecuador, Colombia, Portugal, Oman, Switzerland, Spain, Zimbabwe, Belgium, Brazil, Thailand, Argentina, Costa Rica, Taiwan, ROC, India, Russia, Saudi Arabia, Pakistan, Caribbean, Venezuela.

    Quantity

    240