BEUDAMED
    FDA Enforcement Class II Terminated

    Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643

    Recall: Z-1565-2020 · Reported April 1, 2020

    Enforcement

    Recall Number
    Z-1565-2020
    Event ID
    85187
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2020
    Initiation Date
    March 6, 2020
    Classification Date
    March 24, 2020
    Termination Date
    December 18, 2020
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    Description

    Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643

    Reason

    The printed expiration dates are incorrect.

    Code Info

    Lot Number 10119247; UDI: (01)00827002106437(17)921110(10)10119247

    Distribution

    The products were distributed to the following US states: CO, DE, MD, MN, NC, NV, and WV. The products were distributed to the following foreign countries: Canada.

    Quantity

    25