BEUDAMED
    FDA Enforcement Class II Terminated

    REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107891 - Product Usage: is designed for use when central venous catheterization is prescribed.

    Recall: Z-1667-2021 · Reported May 26, 2021

    Enforcement

    Recall Number
    Z-1667-2021
    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 CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107891 - 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. redz3509 REEN4546 reep4145 reer0944 reer2048 rees1328 rees2108 rees3222 reeu1443 reeu2740 reeu3561 reew4312

    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