BEUDAMED
    FDA Enforcement Class II Ongoing

    Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.

    Recall: Z-2911-2020 · Reported September 9, 2020

    Enforcement

    Recall Number
    Z-2911-2020
    Event ID
    86128
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    C.A. Greiner & Sohne Gesellschaftmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2020
    Initiation Date
    July 27, 2020
    Classification Date
    August 28, 2020
    Address
    Greiner St. #70, N/A, Kremsmunster, N/A, N/A, Austria

    Description

    Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.

    Reason

    Sample leaking from the sleeve covering the needle inside the cannula

    Code Info

    Lot # A19073FK

    Distribution

    US Nationwide distribution including in the states of UT, TN.

    Quantity

    390,000 units