BEUDAMED
    FDA Enforcement Class III Ongoing

    PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.

    Recall: Z-1226-2023 · Reported March 15, 2023

    Enforcement

    Recall Number
    Z-1226-2023
    Event ID
    91614
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Preat Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2023
    Initiation Date
    February 1, 2023
    Classification Date
    March 6, 2023
    Address
    2625 Skyway Dr Ste B, Santa Maria, CA, 93455-1405, United States

    Description

    PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.

    Reason

    Product is labeled with an incorrect expiration date.

    Code Info

    Product #0102000 - Lot #21V0089; UDI 00842092127308. Product #0102000-3 - Lots 21V0089 and 194397; UDI 00842092155660.

    Distribution

    Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. There was also government distribution. The country of Canada.

    Quantity

    652 units