BEUDAMED
    FDA Enforcement Class II Terminated

    Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300

    Recall: Z-0012-2020 · Reported October 9, 2019

    Enforcement

    Recall Number
    Z-0012-2020
    Event ID
    83435
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Inter-Med Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2019
    Initiation Date
    June 27, 2019
    Classification Date
    October 1, 2019
    Termination Date
    August 10, 2021
    Address
    2200 Northwestern Ave, N/A, Racine, WI, 53404-2500, United States

    Description

    Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300

    Reason

    The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.

    Code Info

    Lot/Work Order Numbers: 2018-1348 2018-1585 2018-1586 2018-1852 20182106, UDI (01)10818207020465 20182302, UDI (01)10818207020465 20182458, UDI (01)10818207020465 20190725, UDI (01)10818207020465 20190835, UDI (01)10818207020465

    Distribution

    US, South Africa, Switzerland, Poland, Italy, Singapore, Australia

    Quantity

    1992 units