BEUDAMED
    FDA Recall Terminated

    J-VAC Reservoir is a component of the J-VAC Closed Wound Drainage System. This system is a sterile, portable system used for closed wound drainage. This system is composed of two parts: the J-VAC Reservoir and Suction Drains.

    Recall: Z-0076-06 · Initiated August 31, 2005

    Recall

    Recall Number
    Z-0076-06
    Event Number
    33336
    Firm
    Ethicon, Inc US
    FEI Number
    2210968
    Product Code
    GCY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 31, 2005
    Posted
    October 21, 2005
    Terminated
    July 3, 2006
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    J-VAC Reservoir is a component of the J-VAC Closed Wound Drainage System. This system is a sterile, portable system used for closed wound drainage. This system is composed of two parts: the J-VAC Reservoir and Suction Drains.

    Reason

    Two lots of J-VAC Drain Reservors were shipped to Japan prior to sterilization and were released.

    Action

    Ethicon notified Japan of the recall on 9/2/2005 via phone call and e-mail. This product is direct shipped from Johnson & Johnson Hospital Services distribution center to Japan JJKK.

    Distribution

    The two lots were distributed to Japan. No units were distributed in the US. No government accounts are affected.

    Quantity

    4630 units