BEUDAMED
    FDA Recall Terminated

    Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350

    Recall: Z-0014-2020 · Initiated June 27, 2019

    Recall

    Recall Number
    Z-0014-2020
    Event Number
    83435
    Firm
    Inter-Med Llc
    FEI Number
    3000209941
    Product Code
    KJJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 27, 2019
    Posted
    October 1, 2019
    Terminated
    August 10, 2021
    Address
    2200 Northwestern Ave, Racine, WI, 53404-2500

    Description

    Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350

    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.

    Action

    The firm initiated the recall by letter on 06/27/2019. The letter directed the consignee to quarantine the product and contact the returns department for return instructions.

    Distribution

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

    Quantity

    768 units