BEUDAMED
    FDA Enforcement Class II Terminated

    ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

    Recall: Z-1740-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1740-2018
    Event ID
    79435
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microline Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 16, 2018
    Initiation Date
    November 1, 2017
    Classification Date
    May 8, 2018
    Termination Date
    September 17, 2019
    Address
    50 Dunham Rd, Suite 1500, Beverly, MA, 01915-1882, United States

    Description

    ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

    Reason

    Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.

    Code Info

    Lot Numbers: 70208, 70209, 70210 UDI: 00811099011989

    Distribution

    Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.

    Quantity

    12 box of 10 tips each