BEUDAMED
    FDA Recall Terminated

    Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10 individually packaged scalpels.

    Recall: Z-0767-2007 · Initiated April 9, 2007

    Recall

    Recall Number
    Z-0767-2007
    Event Number
    37759
    Firm
    Miltex, Inc.
    FEI Number
    2518040
    Product Code
    GES
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 9, 2007
    Posted
    April 21, 2007
    Terminated
    August 7, 2007
    Address
    589 Davies Drive, York, PA, 17402-8630

    Description

    Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10 individually packaged scalpels.

    Reason

    Sterility may be compromised based on incomplete package seals (manufacturer notified Miltex)

    Action

    The recalling firm issued a recall letter dated 4/9/07 informing the customers of the problem and the need to return the product. The letter was sent via UPS with a return receipt required to verify delivery. Distributors were notified to sub-recall.

    Distribution

    Nationwide to distributors in CA, FL, IA, ID, NM, NJ, OH, PA, RI, and VA.

    Quantity

    400 boxes