BEUDAMED
    FDA Enforcement Class II Terminated

    Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355

    Recall: Z-0015-2020 · Reported October 9, 2019

    Enforcement

    Recall Number
    Z-0015-2020
    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 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355

    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

    UDI (01)10818207020410 Lot/Work Order Numbers: 20182545 20182665 20190198 20190432 20190724 20190953 20191314

    Distribution

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

    Quantity

    445 units