Device product
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
Z-2026-2025
Product summary
- Event
- Event 96957
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11 units
- Official record key
device-enforcement:Z-2026-2025
Official wording
Reason: The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Code information: Model No JP-24-6. GTIN: 00850043393016. All lots shipped up to May 23, 2025.
Distribution pattern: US Nationwide distribution in the states of IN, NY, PA.
Derived failure modes
-
Unknown
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.