BEUDAMED
    FDA Enforcement Class II Terminated

    REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107822 - Product Usage: is designed for use when central venous catheterization is prescribed.

    Recall: Z-1665-2021 · Reported May 26, 2021

    Enforcement

    Recall Number
    Z-1665-2021
    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 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107822 - 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. redx0702 redx1450 redx2338 redx4128 reep0823 reeq3588 reer1040 reer3480 rees0567 rees1246 rees2299 reew1849 reew4279 reex0353 reex3469

    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