BEUDAMED
    FDA Enforcement Class II Ongoing

    Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter

    Recall: Z-2591-2023 · Reported September 27, 2023

    Enforcement

    Recall Number
    Z-2591-2023
    Event ID
    92850
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ARROW INTERNATIONAL Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    September 27, 2023
    Initiation Date
    August 10, 2023
    Classification Date
    September 15, 2023
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437, United States

    Description

    Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter

    Reason

    This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

    Code Info

    Batch/Lot number 13F22E0359

    Distribution

    US Nationwide distribution.

    Quantity

    177 units