BEUDAMED
    FDA Recall Open, Classified

    BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012

    Recall: Z-1294-2024 · Initiated February 2, 2024

    Recall

    Recall Number
    Z-1294-2024
    Event Number
    93951
    Firm
    Beaver Visitec International, Inc.
    FEI Number
    1211998
    Product Code
    HMX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 2, 2024
    Posted
    March 14, 2024
    Address
    500 Totten Pond Rd, 10, City Point Waltham, MA, 02451-1916

    Description

    BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012

    Reason

    Pack and pouch label is missing the manufacturing and expiration date.

    Action

    Beaver Visitec International issued URGENT FIELD SAFETY NOTICE- FA-24-001 letter on 1/19/24. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine product from these lots that are subject to this FSN. If you have further distributed this product, please notify your customers by initiating a sub-recall. Consider all potential users of this product in your user supply chain. You are encouraged to use a copy of this Field Safety Notification letter when contacting your customers. 2. Complete the enclosed Business Response Form (BRF) and indicate whether or not you have affected product. Please return any affected product to Sedgwick. 3. Please enter the following information on the enclosed BRF: company name, part number(s), lot number(s) and quantity(ies) of device(s). If you have any questions regarding this Field Action, please contact BVI Sedgwick at [email protected] or 8445934007. 4. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Credit will be provided to consignees who have replied with confirmation of receiving affected product. Please include in the subject line: Master Case PIR 00538463 Please direct any questions regarding credit to our customer service department by email: [email protected]:

    Distribution

    Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA, GERMANY, SWITZERLAND, UNITED KINGDOM.

    Quantity

    3,000 units (US and OUS)