Class 2 Device Recall Irrisept Wound Debridement and Cleansing System

• Date Initiated by Firm: August 16, 2019
• Create Date: October 24, 2019
• Recall Status: Terminated on September 25, 2020
• Recall Number: Z-0191-2020
• Recall Event ID: 83599
• 510(K)Number: K080779
• Product Classification: Lavage, jet - Product Code FQH
• Product: Irrisept Wound Debridement and Cleansing System. 12 units per case.
• Code Information: Catalog Number: ISEPT-450-USA; Lot Numbers: 19CAB939, 19DAB431; Expiration Date: 2021-04-30
• Recalling Firm/ Manufacturer: IrriMAX Corporation; 1665 Lakes Pkwy; Lawrenceville GA 30043-5881
• For Additional Information Contact: 844-477-4778
• Manufacturer Reason for Recall: Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
• FDA Determined Cause: Process control
• 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 (customercare@irrimax.com) 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 (customercare@irrimax.com) 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 (customercare@irrimax.com) 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 customercare@irrimax.com by email or toll free 1-844-477-4778.
• Quantity in Commerce: 1,031 cases (12,372 units)
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FQH and Original Applicant = IRRIMAX CORPORATION