BEUDAMED
    FDA Enforcement Class II Ongoing

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/Angioplasty kit), REF: OPT0242-00 S1279-01 S2953 S2960 S6002 To support various vascular or cardiac diagnostic and interventional procedures.

    Recall: Z-2573-2024 · Reported August 21, 2024

    Enforcement

    Recall Number
    Z-2573-2024
    Event ID
    94797
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2024
    Initiation Date
    June 11, 2024
    Classification Date
    August 12, 2024
    Address
    1600 W Merit Pkwy, South Jordan, UT, 84095-2416, United States

    Description

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/Angioplasty kit), REF: OPT0242-00 S1279-01 S2953 S2960 S6002 To support various vascular or cardiac diagnostic and interventional procedures.

    Reason

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

    Code Info

    Catalog Number/UDI-DI code/Lot Numbers: OPT0242-00 00884450400586 T2167632 T2651487 T2327975 T2528428 T2845197 S1279-01 00884450050804 T2281682 T2409038 T2415675 T2449554 T2479912 T2599987 T2610007 T2681504 T2662328 T2713161 T2832455 T2890627 T2748983 T2780193 S2953 00884450050842 T2538578 T2625990 T2548814 T2574370 T2643543 T2702839 T2702565S T2736331 T2801599 T2924139 T2839019 T2890680 T2847794 S2960 00884450389058 T2542575 T2637160 T2872115 S6002 0088445005239 T2208823

    Distribution

    U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

    Quantity

    5700 kits