BEUDAMED
    FDA Recall Terminated

    Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures

    Recall: Z-1111-2019 · Initiated March 12, 2019

    Recall

    Recall Number
    Z-1111-2019
    Event Number
    82382
    Firm
    Beaver Visitec
    FEI Number
    1211998
    Product Code
    HNN
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    March 12, 2019
    Posted
    April 9, 2019
    Terminated
    August 11, 2020
    Address
    500 Totten Pond Rd, 10, City Point Waltham, MA, 02451-1916

    Description

    Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures

    Reason

    Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device

    Action

    Beaver-Visitec International, Inc.(BVI) initiated recall by letter on 3/12/19 advising users of the problem, action to take: immediately examine inventory and quarantine product from this lot subject to mplete and return the enclosed Product Recall Notice Response & Return Form recall, Return ALL quarantined product from the affected lot. Questions you may contact our Customer Service Team at:[email protected] or call 866-906-8080 from 8 A.M. to 6 P.M. EST (Monday-Friday).

    Distribution

    Worldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS

    Quantity

    196 boxes (10units/box)