BEUDAMED
    FDA Recall Terminated

    Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box.

    Recall: Z-0977-03 · Initiated August 7, 2003

    Recall

    Recall Number
    Z-0977-03
    Event Number
    27021
    Firm
    Watson Diagnostics Inc.
    FEI Number
    2024830
    Product Code
    MPU
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 7, 2003
    Posted
    August 26, 2003
    Terminated
    December 14, 2007
    Address
    311 Bonnie Circle, Corona, CA, 92880

    Description

    Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box.

    Reason

    Lights split, spilling contents when bent to activate.

    Action

    Users are instructed to cease use and return the product immediately in a letter issued 8/7/2003 return receipt requested.

    Distribution

    Nationwide.

    Quantity

    662 boxes