BEUDAMED
    FDA Enforcement Class II Terminated

    PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006

    Recall: Z-0744-2022 · Reported March 16, 2022

    Enforcement

    Recall Number
    Z-0744-2022
    Event ID
    89577
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    3-D Matrix, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 16, 2022
    Initiation Date
    December 2, 2019
    Classification Date
    March 10, 2022
    Termination Date
    August 25, 2023
    Address
    1234 Chestnut St Ste 205, N/A, Newton, MA, 02464-1451, United States

    Description

    PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006

    Reason

    The boxes used by the shipper were not validated for use during transport.

    Code Info

    UDI: (01)00860001820829(17)220430(10)19E30A50; Lot Number 19E30A50

    Distribution

    US Nationwide distribution in the state OH.

    Quantity

    3 units