Z-0191-2020Class II

Irrisept Wound Debridement and Cleansing System. 12 units per case

Name: Z-0191-2020 Irrisept Wound Debridement and Cleansing System. 12 units per case
Creator: IrriMAX Corporation
Published: 2019-08-16
License: https://open.fda.gov/license/

IrriMAX Corporation / initiated 2019-08-16 / Terminated / root cause: manufacturing process

FDA source

IrriMAX Corporation began a recall of Irrisept Wound Debridement and Cleansing System. 12 units per case on 2019-08-16. FDA classified it as Class II and gives the reason as "Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0191-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-16
Posted: 2019-10-24
Terminated: 2020-09-25
Recalling firm: IrriMAX Corporation
Product: Irrisept Wound Debridement and Cleansing System. 12 units per case.
Product code: FQH Lavage, Jet
Reason for recall: Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
Root cause tag: manufacturing process
FDA 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 ([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.
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.
Product codes and lots: Catalog Number: ISEPT-450-USA; Lot Numbers: 19CAB939, 19DAB431; Expiration Date: 2021-04-30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0191-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0191-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-23

Product code FQH

K080779Class IIIrrisept Wound Cleansing SystemIrrimax Corporation / cleared 2009-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)