IrriMAX Irrisept Wound Debridement and Cleansing System. 12 units per case recall — FDA Z-0191-2020
Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
Overview of recall records associated with IrriMAX Corporation, including dates, categories and classifications where available.
Classification mix: Class II: 1.
Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
This page summarizes recall records in which the official source identifies IrriMAX Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.