IrriMAX Corporation recalls Irrisept Wound Debridement and Cleansing System. 12 units per case.

Recall date

August 16, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0191-2020

FDA classification

Class II

Brand / firm

IrriMAX Corporation

Sold / distributed

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.

Why it was recalled

Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Irrisept Wound Debridement and Cleansing System. 12 units per case.