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Recall Observatory FDA recall evidence

Device product

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe

Z-0953-2025

December 03, 2024

Class II

Product summary

Firm
Sklar Instruments
Event
Event 95946
Status
Ongoing
Classification
Class II
Quantity
2500 units
Official record key
device-enforcement:Z-0953-2025

Official wording

Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information: 1) 94-5923, UDI/DI 50649111181663, Lot codes: SK-115, SK-116; 2) 96-2361, UDI/DI 50649111392601, Lot codes: SK-115.

Distribution pattern: Domestic: Nationwide Distribution

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach of the sterile barrier