BEUDAMED
    FDA Enforcement Class II Ongoing

    PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿ percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.

    Recall: Z-1912-2026 · Reported April 29, 2026

    Enforcement

    Recall Number
    Z-1912-2026
    Event ID
    98618
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ARROW INTERNATIONAL, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2026
    Initiation Date
    March 11, 2026
    Classification Date
    April 22, 2026
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿ percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.

    Reason

    Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

    Code Info

    Product code:ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 Batch Number: 33F25K0130

    Distribution

    U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.

    Quantity

    115