BEUDAMED
    FDA Enforcement Class II Terminated

    Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589-03

    Recall: Z-0266-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0266-2020
    Event ID
    83927
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Datascope Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2019
    Initiation Date
    October 3, 2019
    Classification Date
    November 1, 2019
    Termination Date
    January 8, 2021
    Address
    1300 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2052, United States

    Description

    Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589-03

    Reason

    One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.

    Code Info

    10000493876

    Distribution

    Distributed to CA, GA, and TX.

    Quantity

    7