BEUDAMED
    FDA Enforcement Class I Terminated

    Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175

    Recall: Z-1848-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1848-2020
    Event ID
    85057
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Applied Medical Resources Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2020
    Initiation Date
    October 24, 2019
    Classification Date
    May 7, 2020
    Termination Date
    June 1, 2023
    Address
    22872 Avenida Empresa, N/A, Rancho Santa Margarita, CA, 92688-2650, United States

    Description

    Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175

    Reason

    The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.

    Code Info

    Model A4GW6, Applied Medical DUAL LUMEN GRAFT CLEANING CATETER, 9mm X 60cm, lot numbers 1267676, 1272322, 1284680, 1295323, 1306127, 1312586, 1330450, 1334826, 1338738, 1339555

    Distribution

    Worldwide distribution - United States: Nationwide OUS: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, South Africa, Spain, Taiwan, United Kingdom

    Quantity

    28,799 catheters in total