Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
- Recall Initiated
- May 22, 2025
- Posted
- June 25, 2025
- Recall Number
- Z-2026-2025
- Quantity
- 11 units
- Firm Location
- Cedar Grove, NJ
Reason for Recall
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Distribution
US Nationwide distribution in the states of IN, NY, PA.
Lot / Code Info
Model No JP-24-6. GTIN: 00850043393016. All lots shipped up to May 23, 2025.
Root Cause
No Marketing Application
Action Taken
Jewel Precision notified consignees on about 05/22/2025 via email. Consignees were instructed to acknowledge the notification, inform Jewel Precision of their distribution of the products, obtain old Instructions for Use from their customers, return any obsolete Instructions for Use to Jewel Precision, and send updated Instructions for Use to their customers.