BEUDAMED
    FDA Recall Terminated

    Codman Plastic Disposable ICP Kit, Adult Product Code: 80-1196 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures

    Recall: Z-2031-2011 · Initiated November 30, 2010

    Recall

    Recall Number
    Z-2031-2011
    Event Number
    57340
    Firm
    Codman & Shurtleff, Inc.
    FEI Number
    3002947440
    Product Code
    GWM
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    November 30, 2010
    Posted
    April 20, 2011
    Terminated
    March 14, 2013
    Address
    325 Paramount Drive, Raynham, MA, 02767

    Description

    Codman Plastic Disposable ICP Kit, Adult Product Code: 80-1196 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures

    Reason

    Packaging defect may compromise sterility of device

    Action

    The firm, Codman, sent an "Important Notice Urgent- Voluntary Product Recall Notification" letter dated November 30, 2010 to its customers via FedX. On January 7, 2011, Codman expanded the recall to four additional product codes.On January 31, 2011, the firm issued a supplemental recall letter and identified one additional product code: 80-11197. The letters described the product, problem and actions to be taken. The customers were instructed to identify the unused affected products in their inventory and follow the recall instructions provided: 1) If you have NO product to return, please advise Codman as soon as possible using the FACSIMILE form attached and fax to 508-828-6118 and 2) if you DO have product to return, please call 1-800-225-0460, Option 4, for instructions for return. Codman is presently working toward supplying replacement products as soon as possible. Please call Customer Service to check on the status of product availability at 1-800-225-0460. Should you have any questions regarding this recall, please call Customer Service at 1-800-225-0460 or your local Codman Representative.

    Distribution

    Worldwide distribution: USA including states of :AL, FL,GA, KY, MA, MI, MN, MS, OR, PA, RI, UT,WI and WV; and countries including: Argentina, Australia, Canada, Bahamas , Belgium, Dubai, Japan, Madrid, Mexico, New Zealand, Saudia Arabia, UAE, Uruguay, and United Kingdom.

    Quantity

    226 units