BEUDAMED
    FDA Recall Terminated

    Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

    Recall: Z-1721-2019 · Initiated July 13, 2018

    Recall

    Recall Number
    Z-1721-2019
    Event Number
    82553
    Firm
    Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
    FEI Number
    2024312
    Product Code
    MED
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    July 13, 2018
    Posted
    July 5, 2019
    Terminated
    May 5, 2021
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    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.

    Action

    On July 13, 2018, Metrex Research Corp., a subsidiary of Kerr Corporation, sent URGENT NOTICE: Regimen Glutaraldehyde letters to their consignees instructing them to check their inventory and complete the enclosed Field Action Acknowledement and Product Return Form. Distributors were requested to conduct sub-recalls to their consignees.

    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