BEUDAMED
    FDA Enforcement Class II Terminated

    Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal for applying ointments, prepping, wiping needles, cleaning slides and more Rayon/polyester blend construction Highly absorbent.

    Recall: Z-0957-2019 · Reported March 6, 2019

    Enforcement

    Recall Number
    Z-0957-2019
    Event ID
    82008
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2019
    Initiation Date
    December 27, 2018
    Classification Date
    February 26, 2019
    Termination Date
    June 29, 2020
    Address
    15 Hampshire St Bldg 5, Mansfield, MA, 02048-1113, United States

    Description

    Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal for applying ointments, prepping, wiping needles, cleaning slides and more Rayon/polyester blend construction Highly absorbent.

    Reason

    Curity All Purpose Sponges were not sterilized and distributed

    Code Info

    Lot Number: 18E190262 Expiration Date: 05/2023

    Distribution

    Worldwide distribution - US Nationwide and countries of Canada, Colombia.

    Quantity

    10,400 units (13 cases, 800 units/case)