BEUDAMED
    FDA Enforcement Class II Terminated

    (1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arrow¿ STIM CPNB TUOHY NDL: 18G x 8CM (3-1/8") AB-18080-N (4) Arrow¿ STIM CPNB TUOHY NDL: 17G x 8CM (3-1/8") AB-17080-N (5) Arrow¿ STIM CPNB TUOHY NDL: 17G x 14CM (5-1/2") AB-17140-N (6) Arrow¿ INSL CPNB TUOHY NDL: 17G x 15CM (6") AB-00150 (7) Arrow¿ STIM CPNB TUOHY NDL: 17G x 11CM (4-3/8") AB-17110-N

    Recall: Z-1253-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1253-2020
    Event ID
    84688
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2020
    Initiation Date
    December 20, 2019
    Classification Date
    February 14, 2020
    Termination Date
    February 25, 2021
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607, United States

    Description

    (1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arrow¿ STIM CPNB TUOHY NDL: 18G x 8CM (3-1/8") AB-18080-N (4) Arrow¿ STIM CPNB TUOHY NDL: 17G x 8CM (3-1/8") AB-17080-N (5) Arrow¿ STIM CPNB TUOHY NDL: 17G x 14CM (5-1/2") AB-17140-N (6) Arrow¿ INSL CPNB TUOHY NDL: 17G x 15CM (6") AB-00150 (7) Arrow¿ STIM CPNB TUOHY NDL: 17G x 11CM (4-3/8") AB-17110-N

    Reason

    Product lidstock contains the incorrect expiration date for the product

    Code Info

    Lot Number: (1) AB-00150 13F16B0155; (2) AB-17080-N 13F18J0654, 13F16H0046,13F16F0210, 13F16E0106, 13F16C0107; (3) AB-17110-N 13F16G0226, 13R16G0226, 13F16F0079; (4) AB-17140-N 13F16F0190, 13F16C0045; (5) AB-18080-N 13F16H0048, 13F16F0007, 13F16B0181, (6) AB-18110-N 13F16F0189, 13F16C0046; (7) AB-18140-N 13F16H0292;

    Distribution

    Nationwide Foreign: AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA

    Quantity

    2126