BEUDAMED
    FDA Recall Open, Classified

    bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809

    Recall: Z-0228-2022 · Initiated October 8, 2021

    Recall

    Recall Number
    Z-0228-2022
    Event Number
    88826
    Firm
    Beaver Visitec International, Inc.
    FEI Number
    1211998
    Product Code
    OJK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 8, 2021
    Address
    500 Totten Pond Rd, 10, City Point Waltham, MA, 02451-1916

    Description

    bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809

    Reason

    Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades

    Action

    BVI notified Consignees by Urgent Medical Device Recall letter on 10/8/21 via registered mail. 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 recall. If you have further distributed this product, please notify your customers by initiating a subrecall. Consider all potential users of this product in your user supply chain. You are encouraged to a copy of this recall notification letter when contacting your customers. 2. Complete the enclosed Business Reply Form (BRF) and indicate whether you have affected product to return. 3. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) that are being returned. 4. Return the completed BRF to BVI by one of these methods: " Fax to 866-552-4919 " Email the attached to [email protected] 5. Return your product to STERICYCLE using the enclosed UPS pre-paid return label: Stericycle 2670 Executive Drive, Suite A Indianapolis, IN 46241 Attn: Event 3997 If you received this notification without the prepaid UPS label and Business Reply Form (BRF), and require additional shipping labels, or if you have questions regarding the return procedure, please contact Stericycle Inc. at 866-606-8264 (Mon.-Fri. 8:00 am - 5:00 pm Eastern Time). Please direct any questions regarding this matter to our customer service department by email [email protected] and please include in the subject line: Master Case PIR 263383

    Distribution

    Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan Russia South Africa UK

    Quantity

    500 eaches