BEUDAMED
    FDA Enforcement Class II Ongoing

    Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular

    Recall: Z-2590-2023 · Reported September 27, 2023

    Enforcement

    Recall Number
    Z-2590-2023
    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 One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular

    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 13F22J0617

    Distribution

    US Nationwide distribution.

    Quantity

    190 units