FDA Medical Device Recalls (openFDA)
IrriMAX Corporation: Irrisept Wound Debridement and Cleansing System. 12 units per case.
- Recall number
- Z-0191-2020
- Recalling firm
- IrriMAX Corporation
- Product
- Irrisept Wound Debridement and Cleansing System. 12 units per case.
- Status
- Terminated
- Initiated
- 2019-08-16
- Posted
- not on file
- Terminated
- 2020-09-25
- Reason
- Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
- Root 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
- 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.
- Lot, serial or model codes
- Catalog Number: ISEPT-450-USA; Lot Numbers: 19CAB939, 19DAB431; Expiration Date: 2021-04-30
- 510(k) numbers
- ["K080779"]
- PMA numbers
- not on file
- Product code
- FQH
- Firm FEI
- 3005706359
- Firm city
- Lawrenceville
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28