BEUDAMED
    FDA Enforcement Class II Terminated

    Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

    Recall: Z-2260-2019 · Reported August 21, 2019

    Enforcement

    Recall Number
    Z-2260-2019
    Event ID
    83287
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Degania Silicone, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 21, 2019
    Initiation Date
    June 28, 2019
    Classification Date
    August 12, 2019
    Termination Date
    October 22, 2020
    Address
    Degania Bet, N/A, Dganya Bet, N/A, N/A, Israel

    Description

    Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

    Reason

    15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

    Code Info

    Lot Codes: 1900956, P1900955

    Distribution

    Nationwide Distribution

    Quantity

    640 units