BEUDAMED
    FDA Enforcement Class II Terminated

    Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284

    Recall: Z-1723-2019 · Reported June 12, 2019

    Enforcement

    Recall Number
    Z-1723-2019
    Event ID
    82692
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2019
    Initiation Date
    April 9, 2019
    Classification Date
    June 4, 2019
    Termination Date
    April 28, 2020
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120, United States

    Description

    Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284

    Reason

    Affected products may have been manufactured with the catheter distal end hole too small

    Code Info

    Lot Number NS7726043

    Distribution

    Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA

    Quantity

    2 kits