# FDA recall Z-0191-2020

> **IrriMAX Corporation** · Class II · device recall initiated 2019-08-16.

## Product

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

## Reason for recall

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

## 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.

## Key facts

- **Recall number:** Z-0191-2020
- **Recalling firm:** IrriMAX Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-16
- **Report date:** 2019-10-30
- **Termination date:** 2020-09-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lawrenceville, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0191-2020

## Citation

> AI Analytics. FDA recall Z-0191-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0191-2020. Source: US FDA. Licensed CC0.

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