BEUDAMED
    FDA Recall Open, Classified

    BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current Part Number: 221251

    Recall: Z-1281-2022 · Initiated April 26, 2022

    Recall

    Recall Number
    Z-1281-2022
    Event Number
    90237
    Firm
    Beaver Visitec International, Inc.
    FEI Number
    1211998
    Product Code
    GEI
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 26, 2022
    Address
    500 Totten Pond Rd, 10, City Point Waltham, MA, 02451-1916

    Description

    BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current Part Number: 221251

    Reason

    Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect product a Wet-Field Eraser, 18GA Bevel Tip, Straight, Part Number: 221250

    Action

    BVI issued Urgent Medical Device Letter dated 4/26/22 via email stating 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 sub-recall. Consider all potential users of this product in your user supply chain. You are encouraged to use a copy of this recall notification letter when contacting your customers. 2. Complete the enclosed Business Response 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 ALL quarantined product from the affected lot to our company utilizing the Return Merchandise Authorization (RMA) sticker label that is included with this letter. You may use the prepaid BVI FedEx number for your return. If you have any specific product replacement questions you may contact our Customer Service Team at: [email protected] or call 866-906-8080 from 8 A.M. to 6 P.M. EST (Monday-Friday)

    Distribution

    US Nationwide distribution in the states of AZ, CA, CT, DC, FL, GA, IN, MA, MN, NV, SC, TX, WA.

    Quantity

    660 units