Z-0191-2020 Class II Terminated
FDA device recall Z-0191-2020 was initiated by IrriMAX Corporation on August 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 September 25, 2020). Affected quantity: 1,031 cases (12,372 units).
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2019
- Initiation Date
- August 16, 2019
- Termination Date
- September 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