BEUDAMED
    FDA Recall Terminated

    Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed.

    Recall: Z-0288-04 · Initiated October 17, 2003

    Recall

    Recall Number
    Z-0288-04
    Event Number
    27490
    Firm
    Ohmeda Medical, A Div of Datex-Ohmeda Inc
    FEI Number
    1121732
    Product Code
    FMZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 17, 2003
    Posted
    July 20, 2004
    Terminated
    October 11, 2005
    Address
    8880 Gorman Rd, Laurel, MD, 20723-5800

    Description

    Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed.

    Reason

    Heater vent door on neonatal incubator may malfunction.

    Action

    The recalling firm notified domestic consignees by certified letter and international distributors by e-mail dated 10/17/2003. The recall notice was incorporated into a firm''s follow-up letter concerning an on-going product correction of the elevating base on the same neonatal beds. The letter advises of the malfunctioning heater door vent and states that the firm will replace all existing vent doors with doors made of higher temperature rated material. Firm will provide retrofit kits for consignee or service representative installation.

    Distribution

    Products were sold to 365 direct accounts around the US and 58 international distributors.

    Quantity

    1404 beds