BEUDAMED
    FDA Enforcement Class II Ongoing

    MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits short-term (<30 days) venous access and catheter introduction to the central circulation.

    Recall: Z-1916-2026 · Reported April 29, 2026

    Enforcement

    Recall Number
    Z-1916-2026
    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

    MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits short-term (<30 days) 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-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 Batch Number: 33F25M0670

    Distribution

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

    Quantity

    90