BEUDAMED
    FDA Recall Terminated

    Multi Absorbers, reference number 8003138, in S/5 Aespire Start-up Kits (each containing 2 Multi Absorbers)

    Recall: Z-0714-03 · Initiated February 12, 2003

    Recall

    Recall Number
    Z-0714-03
    Event Number
    25632
    Firm
    Datex-Ohmeda
    FEI Number
    2183066
    Product Code
    BSF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 12, 2003
    Posted
    April 9, 2003
    Terminated
    July 2, 2004
    Address
    3030 Ohmeda Dr. Box 7550, Madison, WI, 53707

    Description

    Multi Absorbers, reference number 8003138, in S/5 Aespire Start-up Kits (each containing 2 Multi Absorbers)

    Reason

    Multi Absorbers for anesthesia delivery equipment may have missing or damaged filters, exposing the patient to dust from soda lime in the absorbers.

    Action

    Recall letters dated February 12, 2003 requested that the product be removed from use and returned.

    Distribution

    Nationwide in the United States.

    Quantity

    5 S/5 Aespire Start-up kits