BEUDAMED
    FDA Recall Terminated

    Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: 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 hear-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

    Recall: Z-2002-2016 · Initiated May 9, 2016

    Recall

    Recall Number
    Z-2002-2016
    Event Number
    74341
    Firm
    Datascope Corporation
    FEI Number
    1000222374
    Product Code
    DWE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 9, 2016
    Terminated
    March 28, 2017
    Address
    15 Law Dr, Fairfield, NJ, 07004-0011

    Description

    Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: 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 hear-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

    Reason

    Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.

    Action

    Maquet sent via express mail and hand delivered a recall letter and response form dated May 9, 2016 to their sole customer.

    Distribution

    US in the state of GA

    Quantity

    17 units