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Recall Observatory FDA recall evidence

Device product

Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.

Z-2033-2025

May 23, 2025

Class II

Product summary

Firm
Jewel Precision Sheet Metal & Machining Co, Inc.
Event
Event 96958
Status
Ongoing
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-2033-2025

Official wording

Reason: 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.

Code information: Model No JP-24-8. GTIN: 00850043393139. Lot Number: 16899

Distribution pattern: US distribution to Tennessee.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.