Z-0191-2020 Class II Terminated
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