BEUDAMED
    FDA Recall Terminated

    NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 769709.

    Recall: Z-1778-2010 · Initiated May 10, 2010

    Recall

    Recall Number
    Z-1778-2010
    Event Number
    55638
    Firm
    Ohio Medical Corporation
    FEI Number
    1419185
    Product Code
    BTA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 10, 2010
    Posted
    June 7, 2010
    Terminated
    August 19, 2011
    Address
    1111 Lakeside Dr, Gurnee, IL, 60031

    Description

    NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 769709.

    Reason

    Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during use.

    Action

    Ohio Medical sent Urgent Medical Device Recall letters dated 5/7/10 to the direct accounts on 5/10/10, with follow-up telephone calls on 5/11/10. The accounts were informed of the one report of an explosion of the pump, and were requested to take the pumps out of service and return the pumps to Ohio Medical. The accounts were requested to complete and fax back to Ohio Medical the enclosed acknowledgement form indicating the number of pumps being returned. Any questions were directed to Anita Christ at 847-855-6270. Follow-up letters dated 5/13/10 were sent to the accounts on 5/14/10, providing instructions for the return of the pumps and bags. Shipping boxes will be sent to the accounts based on the number of pumps reported on the acknowledgment form.

    Distribution

    Nationwide and internationally to Qatar and Oman

    Quantity

    218 bags