BEUDAMED
    FDA Enforcement Class II Terminated

    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;

    Recall: Z-1410-2020 · Reported March 11, 2020

    Enforcement

    Recall Number
    Z-1410-2020
    Event ID
    84889
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Deroyal Industries, Inc. Lafollette
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2020
    Initiation Date
    February 4, 2020
    Classification Date
    February 28, 2020
    Termination Date
    April 1, 2021
    Address
    1501 E Central Ave, N/A, La Follette, TN, 37766-2892, United States

    Description

    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;

    Reason

    Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

    Code Info

    Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Outpatient Major 89-3865.12, Lot numbers: 47061206 exp. 06/01/2022, 49505579 exp. 03/01/2023, 4955103 exp. 03/01/2023

    Distribution

    US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange

    Quantity

    2,100 units total