BEUDAMED
    FDA Recall Terminated

    Catalog Number: C-TPNS-6.5-90-REDO+. Catheter introducer, Note: This product is not distributed in the U.S. and is sent to foreign affiliates who then apply additional labeling prior to sale in their countries. Cook Inc., Bloomington, IN 47404

    Recall: Z-0904-2008 · Initiated December 7, 2007

    Recall

    Recall Number
    Z-0904-2008
    Event Number
    46151
    Firm
    Cook, Inc.
    FEI Number
    1820334
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    December 7, 2007
    Posted
    April 16, 2008
    Terminated
    April 15, 2008
    Address
    750 Daniels Way, Bloomington, IN, 47404-9120

    Description

    Catalog Number: C-TPNS-6.5-90-REDO+. Catheter introducer, Note: This product is not distributed in the U.S. and is sent to foreign affiliates who then apply additional labeling prior to sale in their countries. Cook Inc., Bloomington, IN 47404

    Reason

    Packaging Problem: The peel-away sheath does not peel uniformly or completely.

    Action

    Cook Inc. initially notified consignees via FEDEX by an Urgent: Product Recall on 12/7/07. The recall was then expanded and consignees were notified on 12/18/08 by another Urgent: Product Recall. The letters instructed any distributors to inform their customers of recall, and all users to return the recalled products and enclosed Recall Response Form to the firm. For additional information, contact 1-800-346-2686.

    Distribution

    Worldwide Distribution- including USA and countries of Argentina, Australia, Canada, Chile, Denmark, Japan, New Zealand and Singapore.

    Quantity

    1,881 of total products