Device product
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Z-1736-2022
Product summary
- Event
- Event 90763
- Status
- Terminated
- Classification
- Class III
- Quantity
- 619 boxes
- Official record key
device-enforcement:Z-1736-2022
Official wording
Reason: Product contains incorrect chemical indicators in packaging.
Code information: UDI-DI (GTIN): 10724995088955 Item Number: LCC003, Lot 3411228A
Distribution pattern: Distribution in the US only - AK, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MN, MO, MS, NE, NH, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WY
Derived failure modes
-
Unknown
Product contains incorrect chemical indicators in packaging.