BEUDAMED
    FDA Recall Terminated

    Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF 427002000, Pink to white. Used with GE Healthcare ADU anesthesia systems. GE Healthcare Finland Oy, Helsinki, Finland +358 10 39411.

    Recall: Z-0291-2007 · Initiated September 11, 2006

    Recall

    Recall Number
    Z-0291-2007
    Event Number
    36326
    Firm
    Datex Ohmeda, Inc
    FEI Number
    2183066
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 11, 2006
    Posted
    December 19, 2006
    Terminated
    December 17, 2011
    Address
    3030 Ohmeda Drive PO Box 7550, zip 53707-7550, Madison, WI, 53707-7550

    Description

    Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF 427002000, Pink to white. Used with GE Healthcare ADU anesthesia systems. GE Healthcare Finland Oy, Helsinki, Finland +358 10 39411.

    Reason

    Certain Compact Absorbers may have an increased resistance to gas flow due to an improperly manufactured foam filter. The increased resistance can cause an elevated pressure at the ventilator end of the inspiratory circuit, but the pressure at the patient may be reduced. This could result in patient hypoventilation and hypoxia.

    Action

    All customers were contacted by letter in September 2006, and provided with a customer reply form. The firm sales some of the Compact Absorbers to distributors and they were asked to notify their Compact Absorber customers. Customers outside the US will be contacted to the end user and then their dealers and distributors. The letter said to immediately discontinue the use of all Compact Absorbers having a lot number as identified (reference codes 427002100 - white to violet color change) and (42700200 - pink to white color change). The affected lot numbers should be isolated and destroyed. Once the Product Verification Form has been received by Fax, Multi-Absorbers or when replacement Compact Absorbers are available will be shipped to customers free of charge.

    Distribution

    Worldwide, including USA, Austria, Australia, Belgium, Canada, Croatia, Germany, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Japan, South Korea, Kuwait, Netherlands, Norway, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

    Quantity

    670,620