BEUDAMED
    FDA Enforcement Class II Terminated

    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4

    Recall: Z-1996-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1996-2020
    Event ID
    85361
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2020
    Initiation Date
    January 2, 2020
    Classification Date
    May 14, 2020
    Termination Date
    September 14, 2022
    Address
    951 Calle Amanecer, N/A, San Clemente, CA, 92673-6212, United States

    Description

    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4

    Reason

    Inability for the guidewire to pass through the needles included with the catheter kits.

    Code Info

    LOT 4330832 UDI:1 0840619 04197 4

    Distribution

    US Consignees including in the states of AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA and WA OUS - Canada.

    Quantity

    20