BEUDAMED
    FDA Recall Open, Classified

    Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630

    Recall: Z-0782-2023 · Initiated November 30, 2022

    Recall

    Recall Number
    Z-0782-2023
    Event Number
    91235
    Firm
    Beaver Visitec International, Inc.
    FEI Number
    1211998
    Product Code
    HNN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 30, 2022
    Posted
    January 4, 2023
    Address
    500 Totten Pond Rd, 10, City Point Waltham, MA, 02451-1916

    Description

    Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630

    Reason

    Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection

    Action

    Beaver Visitec (BVI) issued Urgent Medical Device Recall Letter (FA-22-006) on 11/30/22 via certified mail to Distributors/Customers. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine product from the lot that is subject to this recall. 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. Use a copy of this recall notification letter when contacting your customers. 2. Complete the enclosed Business Response Form (BRF) and indicate whether or not you have affected product to return. Please return the business reply form to [email protected]. 3. Please enter the following information on the enclosed BRF: company name, part number(s), lot number(s) and quantity(ies) of device(s) that are being returned. 4. If you have any questions regarding this Field Action, please contact BVI at 888-708-5723 or [email protected]. If you have affected product, please return product with copy of BRF to: Return your product to STERICYCLE using the enclosed UPS pre-paid return label: Attn: Event 6269 Stericycle 2670 Executive Drive, Suite A, Indianapolis, IN 46241 Credit will be provided to consignees who have replied with confirmation of receiving affected product. Please direct any questions regarding credit to our customer service department by email [email protected] and include in the subject line: Master Case PIR: 387823.

    Distribution

    US Nationwide distribution.

    Quantity

    599 units (US): 410 units; 189 kits