BEUDAMED
    FDA Recall 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 · Initiated February 16, 2017

    Recall

    Recall Number
    Z-1769-2017
    Event Number
    76518
    Firm
    Datascope Corporation
    FEI Number
    1000222374
    Product Code
    DWE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 16, 2017
    Posted
    March 23, 2017
    Terminated
    March 21, 2019
    Address
    15 Law Dr, Fairfield, NJ, 07004-3206

    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.

    Action

    Maquet Inc. was notified by their customer on January 1, 2017. This was a reverse notification. The one impacted customer said they will not return the product since they can easily correct the pigtail connection before use. For further questions regarding this recall, please call (973) 709-7442.

    Distribution

    US Distribution to the state of : CA.

    Quantity

    21 kits