BEUDAMED
    FDA Enforcement Class II Terminated

    The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

    Recall: Z-0507-2018 · Reported February 14, 2018

    Enforcement

    Recall Number
    Z-0507-2018
    Event ID
    78754
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microline Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2018
    Initiation Date
    July 13, 2017
    Classification Date
    February 2, 2018
    Termination Date
    February 6, 2020
    Address
    800 Cummings Ctr Ste 166T, N/A, Beverly, MA, 01915-6171, United States

    Description

    The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

    Reason

    The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.

    Code Info

    All lots of product codes: 3201,3221,3231,3241,3251,3261,3271,3281,3291,3301,3311,3321,3331,3341, 3351,3361,3371,3381,3401,3411,3421,3431 UDI's for listed lots of product codes: 3201-UDI 00811099011644, 3221-UDI 00811099011651, 3231-UDI 00811099011668, 3241-UDI 00811099011675, 3251-UDI 00811099011682, 3261-UDI 00811099011699, 3271-UDI 00811099011705, 3281-UDI 00811099011712, 3291-UDI 00811099011729, 3301-UDI 00811099011859, 3311-UDI 00811099011736, 3321-UDI 00811099011743, 3331-UDI 00811099011767, 3341-UDI 00811099011774, 3351-UDI 00811099011781, 3371-UDI 00811099011804, 3381-UDI 00811099011811, 3401-UDI 00811099011828, 3411-UDI 00811099011835, 3421-UDI 00811099011842, 3431-UDI 00811099011644

    Distribution

    Worldwide Distribution-US (Nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, El Salvador, Hong Kong, India, Indonesia, Malaysia, Mexico, Panama, Peru, Argentina, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay & Vietnam.

    Quantity

    61,769 units