BEUDAMED
    FDA Recall Terminated

    Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8, G12403.

    Recall: Z-2076-2010 · Initiated April 21, 2010

    Recall

    Recall Number
    Z-2076-2010
    Event Number
    56084
    Firm
    Cook, Inc.
    FEI Number
    1820334
    Product Code
    JOH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 21, 2010
    Posted
    July 26, 2010
    Terminated
    January 23, 2012
    Address
    750 Daniels Way, Bloomington, IN, 47404-9120

    Description

    Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8, G12403.

    Reason

    These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a result of the pilot balloon inflation assembly.

    Action

    Cook Medical sent an Urgent Product Recall letter dated April 21, 2010, to hospitals and other user facilities receiving product direct from Cook as well as distribution centers receiving direct shipments from Cook. Consignees were directed to cease distribution of product and notify their customers immediately.

    Distribution

    Worldwide distribution: USA, Canada, Mexico, Australia, Chile, Costa Rica, Denmark, Dominican Republic, Guatemala, India, Malaysia, Panama, Peru, Puerto Rico, Republic of Korea, Trinidad and Tobago, and Uruguay.

    Quantity

    28819 total, all products