BEUDAMED
    FDA Recall Terminated

    DeVilbiss iFill Personal Oxygen Station model number 535D.

    Recall: Z-0038-2007 · Initiated August 24, 2006

    Recall

    Recall Number
    Z-0038-2007
    Event Number
    36174
    Firm
    Sunrise Medical
    FEI Number
    2515872
    Product Code
    CAW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 24, 2006
    Posted
    October 17, 2006
    Terminated
    August 27, 2009
    Address
    100 Devilbiss Dr, Somerset, PA, 15501-2125

    Description

    DeVilbiss iFill Personal Oxygen Station model number 535D.

    Reason

    Potential for oxygen cylinders to not fill completely

    Action

    The recalling firm began to notify customers via telephone beginning on 8/24/06. An 'Urgent Medical Device Recall' letter was sent on 8/28/06. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. A customer service help line has been established (1-800-333-4000) to provide additional information for returning units.

    Distribution

    The product was distriubted to 252 end users nationwide through 36 dealers.

    Quantity

    252 units