BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0191-2020 · Initiated August 16, 2019

    Recall

    Recall Number
    Z-0191-2020
    Event Number
    83599
    Firm
    IrriMAX Corporation
    FEI Number
    3005706359
    Product Code
    FQH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 16, 2019
    Terminated
    September 25, 2020
    Address
    1665 Lakes Pkwy, Lawrenceville, GA, 30043-5881

    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.

    Action

    Irrimax Corporation notified customers on about 08/16/2019 via "URGENT: MEDICAL DEVICE RECALL" letter. The letter informed customers that the recall was due to the potential of a defect in the sterile pouch seal, which may result in a lack of sterility assurance, and that the seal defect is not easily visible upon inspection of the pouch. Instructions to customers included, that within 10 business days of receiving the recall notification, they are to discontinue use of the recalled product (labeled lot numbers 19CAB939 or 19DAB431), complete and return the attached Recall Return Response Customer Acknowledgement and Receipt for to Irrimax by email ([email protected]) or mail (Irrimax Corporation, 1665 Lakes Parkway, Suite 102, Lawrenceville, GA 30043), and arrange to return any unused affected product by following the Product Return Instructions provided. Distributors were instructed to discontinue use of the recalled product (labeled lot numbers 19CAB939 or 19DAB431), quarantine any inventory from the recalled lots to ensure product will no longer be distributed, complete and return the attached Recall Return Response Customer Acknowledgement and Receipt for to Irrimax by email ([email protected]) or mail (Irrimax Corporation, 1665 Lakes Parkway, Suite 102, Lawrenceville, GA 30043), and provide a customer distribution list with customer, name, address, telephone numer and email address (contact information) and send to Irrimax via email ([email protected]) by August 23, 2019. Irrimax will send the customer a letter and follow-up with the customer to return all unused product. Additionally, distributors were asked to return recalled product in inventory by following the Product Return Instructions provided. Questions can be directed to [email protected] by email or toll free 1-844-477-4778.

    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)