BEUDAMED
    FDA Recall Terminated

    MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400

    Recall: Z-0011-2011 · Initiated September 7, 2010

    Recall

    Recall Number
    Z-0011-2011
    Event Number
    56728
    Firm
    Maquet Inc.
    FEI Number
    3008355164
    Product Code
    DWE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 7, 2010
    Posted
    October 6, 2010
    Terminated
    September 25, 2012
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470

    Description

    MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400

    Reason

    Tubing packs may contain defective 1/2 inch x 1/2 inch tubing connectors. Leaks at the shank of the connector may result in air aspiration in the venous line.

    Action

    Maquet Getigne Group issued Product Recall/Urgent Medical Device Corrective Action letters dated September 7, 2010 to customers, identifying the affected product, the issue prompting the recall, and actions to be taken by customers.Customers are to check their inventory for affected product. Customers with affected product are to contact Laura Olilver at 201-995-8849 for an RMA number and shipment instructions. All firms are to coomplete and return the Corrective Action Response Form. Maquet Customer Service can bre contacted at 800-777-4222.

    Distribution

    Worldwide Distribution: USA State of IL and country of the Netherlands.

    Quantity

    22 items