BEUDAMED
    FDA Enforcement Class II Terminated

    SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.

    Recall: Z-0389-2017 · Reported November 16, 2016

    Enforcement

    Recall Number
    Z-0389-2017
    Event ID
    75388
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Akita Sumitomo Bakelite Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 16, 2016
    Initiation Date
    September 9, 2016
    Classification Date
    November 9, 2016
    Termination Date
    November 10, 2016
    Address
    27-4, Aza Nakajimita, Akita, N/A, Japan

    Description

    SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.

    Reason

    Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type

    Code Info

    Lot No.: 60564713

    Distribution

    US in the states of MA

    Quantity

    8 units