BEUDAMED
    FDA Recall Terminated

    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08

    Recall: Z-1417-2020 · Initiated February 4, 2020

    Recall

    Recall Number
    Z-1417-2020
    Event Number
    84889
    Firm
    Deroyal Industries, Inc. Lafollette
    FEI Number
    3005011024
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Environmental control
    Initiated
    February 4, 2020
    Posted
    February 19, 2020
    Terminated
    April 1, 2021
    Address
    1501 E Central Ave La, Follette, TN, 37766-2892

    Description

    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08

    Reason

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

    Action

    DeRoyal issued their recall on 1/26/2020 to the end user level by sending recall letters to its direct accounts. The customers were asked to identify the affected products and return the provided notice of return form back to DeRoyal indicating if replacement or credit is requested.

    Distribution

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

    Quantity

    2100 units