BEUDAMED
    FDA Enforcement Class II Terminated

    InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.

    Recall: Z-0676-2016 · Reported January 27, 2016

    Enforcement

    Recall Number
    Z-0676-2016
    Event ID
    72997
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Rymed Technologies, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 27, 2016
    Initiation Date
    January 5, 2016
    Classification Date
    January 21, 2016
    Termination Date
    October 19, 2016
    Address
    6000 W William Cannon Dr Ste B300, N/A, Austin, TX, 78749-1991, United States

    Description

    InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.

    Reason

    Potential for the female luer component of the InVision-Plus IV connector to crack during use.

    Code Info

    Catalog number RYM-7001 Lots: R01842, R01889, R01891, and R01897, Expire 03/2016.

    Distribution

    US Nationwide Distribution.

    Quantity

    46,600 units