BEUDAMED
    FDA Recall 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 · Initiated January 2, 2020

    Recall

    Recall Number
    Z-1996-2020
    Event Number
    85361
    Firm
    ICU Medical, Inc.
    FEI Number
    2025816
    Product Code
    DQE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 2, 2020
    Terminated
    September 14, 2022
    Address
    951 Calle, Amanecer San Clemente, CA, 92673-6212

    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.

    Action

    The firm has contracted Stericycle, Inc., Indianapolis, IN for customer notification, response tracking and effectiveness check. On 02 January 2020, Stericycle, Inc. sent URGENT: MEDICAL DEVICE RECALL notification of the market action to the firm's direct consignees of record.

    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