BEUDAMED
    FDA Recall Terminated

    BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits

    Recall: Z-1804-2015 · Initiated May 1, 2015

    Recall

    Recall Number
    Z-1804-2015
    Event Number
    71293
    Firm
    Beaver-Visitec International Inc.
    FEI Number
    1211998
    Product Code
    FSY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 1, 2015
    Posted
    June 15, 2015
    Terminated
    January 28, 2021
    Address
    411 Waverley Oaks Rd, Ste 229, Waltham, MA, 02452-8422

    Description

    BVI Custom Eyes Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits

    Reason

    Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product

    Action

    Beaver-Visitec International Sales Ltd. (BVI) sent an Urgent Field Safety Notice dated May 2, 2015, to all affected customers. Customers were instructed to quarantine the affected kits and return to BVI for subsequent replacement of product. A Verification Form was provided to confirm receipt of the recall notice. For questions regarding this recall call 791-906-7950.

    Distribution

    Nationwide Distribution including KY, GA, MI, and NJ.

    Quantity

    585 kits