BEUDAMED
    FDA Recall Terminated

    Stryker brand Neptune waste management system; model 711-27-1.

    Recall: Z-0524-03 · Initiated December 3, 2002

    Recall

    Recall Number
    Z-0524-03
    Event Number
    25142
    Firm
    Stryker Instruments, Instruments Div.
    FEI Number
    1811755
    Product Code
    FYD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 3, 2002
    Posted
    February 1, 2003
    Terminated
    July 7, 2003
    Address
    4100 E. Milham, Kalamazoo, MI, 49001

    Description

    Stryker brand Neptune waste management system; model 711-27-1.

    Reason

    Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R.

    Action

    Each account was contacted by phone, beginning on December 3, 2002 and advised to refrain from using the units until repairs could be performed. A recall notification letter dated December 6, 2002 was sent to each account informing them of the recall and of plans for repairs.

    Distribution

    United States

    Quantity

    370