BEUDAMED
    FDA Enforcement Class II Terminated

    Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

    Recall: Z-1721-2019 · Reported June 12, 2019

    Enforcement

    Recall Number
    Z-1721-2019
    Event ID
    82553
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2019
    Initiation Date
    July 13, 2018
    Classification Date
    June 4, 2019
    Termination Date
    May 5, 2021
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422, United States

    Description

    Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

    Reason

    Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.

    Code Info

    Part Number: 10-6465 (McKesson Reorder # 341) Lot Numbers: 16 1250, 16 1274, 16 1324A, 16 1324B, 16 2337, 17 1038, 17 1038A, 17 1083, 17 1193, 17 1262, 17 2122, 17 2142, 17 2219, 17 2306, 17 2347A, 18 1092B, 18 1121, 18 2037, and 18 3164.

    Distribution

    AZ, CA, CO, FL, GA, IL, KY, LA, MA, MN, MO, NJ, NY, OH, PA, SC, TN, TX, UT, VA, and WA.

    Quantity

    31904