BEUDAMED
    FDA Recall Terminated

    Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.

    Recall: Z-2740-2018 · Initiated June 18, 2018

    Recall

    Recall Number
    Z-2740-2018
    Event Number
    80565
    Firm
    Beaver Visitec
    FEI Number
    1211998
    Product Code
    HNN
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    June 18, 2018
    Terminated
    October 30, 2019
    Address
    500 Totten Pond Rd, 10, City Point Waltham, MA, 02451-1916

    Description

    Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.

    Reason

    Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton.

    Action

    BVI issued PRODUCT RECALL NOTICES to customers dated June 11, 2018. Customers were instructed to inspect stock, quarantine and destroy product per internal procedures. BVI is kindly asking the customers to provide objective evidence of product destruction so that a credit can be applied to accounts. Customers are also encouraged to complete and return the response form. If you have questions regarding this recall please call Customer Service at 866-906-8080.

    Distribution

    Distribution to US states of CA, IL, MD, MN, NJ, OH & PA; and Israel

    Quantity

    440