BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0782-2023 · Reported January 11, 2023

    Enforcement

    Recall Number
    Z-0782-2023
    Event ID
    91235
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beaver Visitec International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 11, 2023
    Initiation Date
    November 30, 2022
    Classification Date
    January 4, 2023
    Address
    500 Totten Pond Rd, 10 City Point, Waltham, MA, 02451-1916, United States

    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

    Code Info

    UDI: 00886158100010 Lot Number: 3391035 Additionally Packaged as a component of the READYPAK KIT Cat: 584896 Lots: 6054175, 6053035

    Distribution

    US Nationwide distribution.

    Quantity

    599 units (US): 410 units; 189 kits