BEUDAMED
    FDA Enforcement Class II Terminated

    Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.

    Recall: Z-1246-2016 · Reported March 30, 2016

    Enforcement

    Recall Number
    Z-1246-2016
    Event ID
    73197
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Anspach Effort, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 30, 2016
    Initiation Date
    November 2, 2015
    Classification Date
    March 24, 2016
    Termination Date
    May 6, 2016
    Address
    4500 Riverside Dr, N/A, Palm Beach Gardens, FL, 33410-4235, United States

    Description

    Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.

    Reason

    Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498).

    Code Info

    Model/Catalog: IRR-Clip-30 Lot # J023101962

    Distribution

    Distributed in the states of PA and MN, and the country of Switzerland.

    Quantity

    50 clips