Z-0191-2020 Class II Terminated
FDA device recall Z-0191-2020 was initiated by IrriMAX Corporation on Aug 16, 2019 and is designated Class II. Reason for recall: Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance. The recall status is terminated (terminated Sep 25, 2020). Affected quantity: 1,031 cases (12,372 units).
Recall Details
- Product Type
- Devices
- Report Date
- Oct 30, 2019
- Initiation Date
- Aug 16, 2019
- Termination Date
- Sep 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,031 cases (12,372 units)
Product Description
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 Pattern
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.
Code Information
Catalog Number: ISEPT-450-USA; Lot Numbers: 19CAB939, 19DAB431; Expiration Date: 2021-04-30