BEUDAMED
    FDA Enforcement Class II Terminated

    REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UDI: (01)10801741075268 - Product Usage: is designed for use when central venous catheterization is prescribed.

    Recall: Z-1658-2021 · Reported May 26, 2021

    Enforcement

    Recall Number
    Z-1658-2021
    Event ID
    87594
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Access Systems Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 26, 2021
    Initiation Date
    April 7, 2021
    Classification Date
    May 20, 2021
    Termination Date
    June 1, 2023
    Address
    605 N 5600 W, N/A, Salt Lake City, UT, 84116-3738, United States

    Description

    REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UDI: (01)10801741075268 - Product Usage: is designed for use when central venous catheterization is prescribed.

    Reason

    Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock

    Code Info

    Lot No. redr1671 reds4453 redt1612 redt2758 redt3914 redu0326 redu3286 redu3402 redu4194 redu4226 redv1248 redv2001 redv2750 redw0124 redx3813 redx3828 redy1863 redy2874 redy3867 redz0552 redz1927 redz3505 REEN1390 reen1396 reeq1509 reet2730 reet3239 reeu0563 reew2029 reex2346 reex3092 reey2704 reex3917

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AK, AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI and the countries of Australia, Belgium, Canada, China, Japan, Taiwan, Hong Kong, Malaysia, Chile, Bangladesh, Korea, Brazil, India, Singapore, Thailand.

    Quantity

    N/A