Lawrenceville, GA, United States
IrriMAX Corporation recalls
1 recall recorded since 2018, most recently on 16 August 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 16 August 2019
- Terminated
- 25 September 2020
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0191-2020
- Irrisept Wound Debridement and Cleansing System. 12 units per case.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.