BEUDAMED
    FDA Enforcement Class II Terminated

    Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.

    Recall: Z-2178-2018 · Reported June 20, 2018

    Enforcement

    Recall Number
    Z-2178-2018
    Event ID
    80081
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Datascope Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2018
    Initiation Date
    July 27, 2017
    Classification Date
    June 13, 2018
    Termination Date
    February 7, 2020
    Address
    15 Law Dr, N/A, Fairfield, NJ, 07004-3206, United States

    Description

    Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.

    Reason

    There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.

    Code Info

    UDI 0607567204133

    Distribution

    The products were distributed to the following US states: IA and FL.

    Quantity

    10