BEUDAMED
    FDA Enforcement Class II Terminated

    Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.

    Recall: Z-2773-2016 · Reported September 21, 2016

    Enforcement

    Recall Number
    Z-2773-2016
    Event ID
    74898
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2016
    Initiation Date
    February 17, 2016
    Classification Date
    September 9, 2016
    Termination Date
    October 18, 2017
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.

    Reason

    Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

    Code Info

    Lot/Batch Numbers: 23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285

    Distribution

    US Distribution to states of: NC, OH, FL, and MD.

    Quantity

    6,121 units in total