BEUDAMED
    FDA Recall Terminated

    BD Beaver XStar Safety 2.5mm Crescent Knife; REF 378234 Crescent blades are used in a variety of ophthalmic surgery. Product is a cataract surgery knife designed for optimal tunnel architecture.

    Recall: Z-1894-2011 · Initiated February 28, 2011

    Recall

    Recall Number
    Z-1894-2011
    Event Number
    58109
    Firm
    Beaver-Visitec International Inc.
    FEI Number
    1211998
    Product Code
    H--NN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 28, 2011
    Posted
    April 5, 2011
    Terminated
    June 14, 2012
    Address
    411 Waverley Oaks Rd, Ste 229, Waltham, MA, 02452-8422

    Description

    BD Beaver XStar Safety 2.5mm Crescent Knife; REF 378234 Crescent blades are used in a variety of ophthalmic surgery. Product is a cataract surgery knife designed for optimal tunnel architecture.

    Reason

    Loose blades in the handle of knives due to uncured epoxy.

    Action

    Beaver Visitec International, Inc.sent an Urgent Recall Notification letter dated February 25, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all unused product and to complete a Customer Response Form (to be returned via fax to 866-906-4304. For questions regarding this recall call 781-906-7917.

    Distribution

    Worldwide Distribution - USA including AZ, MA, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, VA and the country of China

    Quantity

    1680 units (1130 domestic, 550 foreign)