BEUDAMED
    FDA Enforcement Class I Terminated

    Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer

    Recall: Z-0352-2023 · Reported December 21, 2022

    Enforcement

    Recall Number
    Z-0352-2023
    Event ID
    91090
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    ARROW INTERNATIONAL Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2022
    Initiation Date
    October 27, 2022
    Classification Date
    December 9, 2022
    Termination Date
    October 7, 2024
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer

    Reason

    There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.

    Code Info

    a) ASK-42703-NS: UDI/DI 10801902162905, Lot Numbers: 13F22B0495 b) ASK-42703-PCCH2: UDI/DI 10801902141030, Lot Numbers: 13F22C0862 c) ASK-42703-PUPM1: UDI/DI 10801902159592, Lot Numbers: 13F22B0021 d) ASK-45703-NS: UDI/DI 10801902162912, Lot Numbers: 13F22C0244 e) ASK-45703-PAU: UDI/DI 10801902159110, Lot Numbers: 13F22D0121 f) ASK-45703-PCAM1: UDI/DI 10801902203158, Lot Numbers: 13F22C0553 g) ASK-45703-PCCH2: UDI/DI 10801902141047, Lot Numbers: 13F22B0641 h) ASK-45703-PN: UDI/DI 10801902140675, Lot Numbers: 13F22C0350

    Distribution

    US Distributor in states of: FL, GA, KY, OH, PA and WV.

    Quantity

    1275 units