BEUDAMED
    FDA Enforcement Class II Terminated

    Irrisept Wound Debridement and Cleansing System. 12 units per case.

    Recall: Z-0191-2020 · Reported October 30, 2019

    Enforcement

    Recall Number
    Z-0191-2020
    Event ID
    83599
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    IrriMAX Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2019
    Initiation Date
    August 16, 2019
    Classification Date
    October 23, 2019
    Termination Date
    September 25, 2020
    Address
    1665 Lakes Pkwy, Lawrenceville, GA, 30043-5881, United States

    Description

    Irrisept Wound Debridement and Cleansing System. 12 units per case.

    Reason

    Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.

    Code Info

    Catalog Number: ISEPT-450-USA; Lot Numbers: 19CAB939, 19DAB431; Expiration Date: 2021-04-30

    Distribution

    Nationwide distribution to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV.

    Quantity

    1,031 cases (12,372 units)