BEUDAMED
    FDA Enforcement Class II Terminated

    QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System

    Recall: Z-1149-2017 · Reported February 15, 2017

    Enforcement

    Recall Number
    Z-1149-2017
    Event ID
    76146
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Leibinger GmbH & Co. KG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 15, 2017
    Initiation Date
    January 3, 2017
    Classification Date
    February 8, 2017
    Termination Date
    July 27, 2017
    Address
    Botzinger Strasse 41, N/A, Freiburg, N/A, N/A, Germany

    Description

    QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System

    Reason

    An incorrect sterility status on the label, non-sterile products labeled as sterile

    Code Info

    Part # 6630 QUINTUBE Monitor Pack Lots- M1305008, M1305009, M1305010, M1305011, M1309004, M1309005, M1309006, M1309007, M1309008, M1309009, M1309010, M1607009, M1607010, T1309003 Part # 6649 SPG Bulb Drain System, 4mm Flat w/Center Holes Lot - M1508003

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.

    Quantity

    619