BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the heart-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.

    Recall: Z-1769-2017 · Reported April 19, 2017

    Enforcement

    Recall Number
    Z-1769-2017
    Event ID
    76518
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Datascope Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2017
    Initiation Date
    February 16, 2017
    Classification Date
    April 10, 2017
    Termination Date
    March 21, 2019
    Address
    15 Law Dr, N/A, Fairfield, NJ, 07004-3206, United States

    Description

    Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the heart-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.

    Reason

    A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap remained on the center port.

    Code Info

    Lot number 3000033848

    Distribution

    US Distribution to the state of : CA.

    Quantity

    21 kits