Device product
Irrisept Wound Debridement and Cleansing System. 12 units per case.
Z-0191-2020
Product summary
- Event
- Event 83599
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,031 cases (12,372 units)
- Official record key
device-enforcement:Z-0191-2020
Official wording
Reason: Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
Code information: Catalog Number: ISEPT-450-USA; Lot Numbers: 19CAB939, 19DAB431; Expiration Date: 2021-04-30
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.
Derived failure modes
-
Sterility assurance
lack of sterility