BEUDAMED
    FDA Enforcement Class II Terminated

    Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282

    Recall: Z-1722-2019 · Reported June 12, 2019

    Enforcement

    Recall Number
    Z-1722-2019
    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 Set, RPN C-PCS-850, Order # G03282

    Reason

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

    Code Info

    Lot Numbers 7716007 7703324 NS7703501 NS7703502 NS7703503 NS7704718 NS7704722 NS7704727 NS7704728

    Distribution

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

    Quantity

    83 kits