BEUDAMED
    FDA Enforcement Class II Terminated

    Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.

    Recall: Z-1233-2017 · Reported March 1, 2017

    Enforcement

    Recall Number
    Z-1233-2017
    Event ID
    76368
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Degania Silicone, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 1, 2017
    Initiation Date
    January 31, 2017
    Classification Date
    February 22, 2017
    Termination Date
    April 4, 2017
    Address
    Degania Bet, N/A, Dganya Bet, N/A, N/A, Israel

    Description

    Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.

    Reason

    Product sterility compromised due to breach of sterile barrier

    Code Info

    Lot Number: P1546816 Expiration date: January 2021

    Distribution

    To PR only

    Quantity

    3040 units