BEUDAMED
    FDA Enforcement Class II Terminated

    Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.

    Recall: Z-0861-2016 · Reported March 2, 2016

    Enforcement

    Recall Number
    Z-0861-2016
    Event ID
    73168
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Centurion Medical Products Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2016
    Initiation Date
    January 19, 2016
    Classification Date
    February 23, 2016
    Termination Date
    July 19, 2016
    Address
    100 Centurion Way, N/A, Williamston, MI, 48895-9086, United States

    Description

    Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.

    Reason

    Convenience Kits contain an In-Vision-Plus Needleless IV Connector, code RYM5001 that is being recalled by the manufacturer, RyMed Technologies, LLC. A component molding abnormality may cause female luer threads to crack, leading to potential for the mating tubing set to become detached and for the administration to be interrupted. Other components within these kits are not affected.

    Code Info

    ECVC1010 CVC INSERTION BUNDLE - 3L, 16CM Batch Exp. 2015042150 12/2016 2015061050 01/2017 2015062650 02/2017 2015071050 03/2017 2015081150 03/2017 ECVC1025 16CM CENTRAL LINE BUNDLE Batch Exp. 2015052750 12/2016 2015062250 01/2017 2015070150 02/2017 2015070950 03/2017 2015080650 03/2017 ECVC1425 20CM CENTRAL LINE BUNDLE Batch Exp. 2015041450 12/2016 2015052250 12/2016 2015062250 01/2017 2015070150 02/2017 ECVC1780 TRIPLE LUMEN BUNDLE Batch Exp. 2015041450 01/2017 2015081350 05/2017 ECVC1785 QUAD LUMEN BUNDLE Batch Exp. 2015052150 01/2017 2015061850 03/2017 ECVC3015 CVC TRIPLE LUMEN BUNDLE Batch Exp. 2015061050 01/2017 2015061850 01/2017 ECVC3260 CVC INSERT BUNDLE 16CM Batch Exp. 2015061150 09/2016 2015061550 09/2016 ECVC3540 TRIPLE LUMEN PI CVC BUNDLE Batch Exp. 2015041350 12/2016 ECVC3575 CVC TRIPLE LUMEN BUNDLE - 20CM Batch Exp. 2015041550 10/2016 2015061050 01/2017 ECVC3915 VANTEX TLC KIT: CURVED SUTURE NEEDLE Batch Exp. 2015040850 02/2017 2015042750 02/2017 2015070250 03/2017 2015081150 05/2017 ECVC3925 9F INTRODUCER: CURVED SUTURE NEEDLE Batch Exp. 2015071750 01/2017 ECVC405 CVC MULTI-LUMEN INSERTION BUNDLE Batch Exp. 2015041750 12/2016 2015061050 01/2017 ECVC4095 AVA HIGH FLOW BUNDLE Batch Exp. 2015060450 08/2016 ECVC4110 MULTI-MED TLC KIT: CURVED SUTURE NDL Batch Exp. 2015060150 03/2017 2015061550 03/2017 2015080750 04/2017 ECVC4115 6FR INTRODUCER: CURVED SUTURE NEEDLE Batch Exp. 2015080550 01/2017 ECVC4170 AVA 3xi CVC BUNDLE Batch Exp. 2015070250 06/2016

    Distribution

    US Distribution in states of: TX, FL, VA, TN, PA, IL, GA, and CA.

    Quantity

    1130