BEUDAMED
    FDA Enforcement Class II Terminated

    HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 2000 Electrosurgical Units or with cases of P/N 7-796-19 sold in cases as P/N 7-796-19BX or P/N 7-796-19CS.

    Recall: Z-1760-2017 · Reported April 19, 2017

    Enforcement

    Recall Number
    Z-1760-2017
    Event ID
    76482
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ConMed Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2017
    Initiation Date
    February 28, 2017
    Classification Date
    April 7, 2017
    Address
    525 French Rd, N/A, Utica, NY, 13502-5945, United States

    Description

    HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 2000 Electrosurgical Units or with cases of P/N 7-796-19 sold in cases as P/N 7-796-19BX or P/N 7-796-19CS.

    Reason

    For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were Sterile.

    Code Info

    Affected Lot Numbers: 201511234, 201512074, 201512094, 201601064, 201603284

    Distribution

    Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.

    Quantity

    N/A