Z-2033-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 2, 2025
- Initiation Date
- May 23, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Reason for Recall
The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.
Distribution Pattern
US distribution to Tennessee.
Code Information
Model No JP-24-8. GTIN: 00850043393139. Lot Number: 16899