BEUDAMED
    FDA Enforcement Class I Terminated

    DeRoyal Heart Cath Procedure Pack, REF 89-6556.08

    Recall: Z-1833-2021 · Reported June 16, 2021

    Enforcement

    Recall Number
    Z-1833-2021
    Event ID
    87949
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 16, 2021
    Initiation Date
    May 14, 2021
    Classification Date
    June 10, 2021
    Termination Date
    April 21, 2023
    Address
    200 Debusk Ln, N/A, Powell, TN, 37849-4703, United States

    Description

    DeRoyal Heart Cath Procedure Pack, REF 89-6556.08

    Reason

    DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine

    Code Info

    Lot Numbers: 54310362, exp. 01/01/2022; 54366825, exp. 01/01/2022

    Distribution

    US Nationwide distribution to the states of MS, VA, LA, and NY.

    Quantity

    66 packs