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IrriMAX Corporation recalls Irrisept Wound Debridement and Cleansing System. 12 units per case.
Recalled October 30, 2019 · FDA recall Z-0191-2020 · IrriMAX
Hazard
Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance. · FDA Class II
Units
1,031 cases (12,372 units)
Sold at
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.
Description
Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
Product
Irrisept Wound Debridement and Cleansing System. 12 units per case.
Manufacturer(s)
IrriMAX Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →