BEUDAMED
    FDA Enforcement Class III Terminated

    Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm 30¿ is a sharp pointed tip intended for ophthalmic, ENT and other forms of surgery stab incisions and other microsurgical techniques. .

    Recall: Z-1088-2019 · Reported April 10, 2019

    Enforcement

    Recall Number
    Z-1088-2019
    Event ID
    82248
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beaver Visitec
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2019
    Initiation Date
    February 19, 2019
    Classification Date
    April 4, 2019
    Termination Date
    July 21, 2020
    Address
    500 Totten Pond Rd, 10 City Point, Waltham, MA, 02451-1916, United States

    Description

    Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm 30¿ is a sharp pointed tip intended for ophthalmic, ENT and other forms of surgery stab incisions and other microsurgical techniques. .

    Reason

    The product contains a misprinted expiration date on the peel pack. Both were printed as "180615", which is the lot number. The Lot number is correct.

    Code Info

    Lot Number 180615

    Distribution

    US Nationwide Distribution to states of : AL, AZ, CA, FL, ID, MN, MO, NY, OH, PA, and TX; and internationally to: Ireland and UK.

    Quantity

    97 boxes (10units/box)