BEUDAMED
    FDA Enforcement Class II Terminated

    InVision-Plus and InVision-Plus Junior Needleless IV Connector, 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-0675-2016 · Reported January 27, 2016

    Enforcement

    Recall Number
    Z-0675-2016
    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 and InVision-Plus Junior Needleless IV Connector, 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

    InVision-Plus Catalog number RYM-5000 Lots 610, 611, 613, 614; Catalog number RYM-5001 Lots R01777, R01789, R01807, R01817, R01822, R01827, R01839, R01848, R01857, R01860, R01871, and R01874; Catalog number RYM-5001CL Lots R01825, R01887, and R01890. InVision Plus Junior Catalog number RYM-8001 Lot R01853.

    Distribution

    US Nationwide Distribution.

    Quantity

    496,400 units