FDA-Device2019-10-30Class II
Irrisept Wound Debridement and Cleansing System. 12 units per case.
IrriMAX Corporation
Hazard
Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
Sold states
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.
Affected count
1,031 cases (12,372 units)
Manufactured in
1665 Lakes Pkwy, Lawrenceville, GA, United States
Products
Irrisept Wound Debridement and Cleansing System. 12 units per case.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0191-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief