Skip to content
Recall Observatory FDA recall evidence

Device product

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal procedures

Z-0930-2025

December 03, 2024

Class II

Product summary

Firm
Sklar Instruments
Event
Event 95946
Status
Ongoing
Classification
Class II
Quantity
175 units
Official record key
device-enforcement:Z-0930-2025

Official wording

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

Code information: 1) 96-2236, UDI/DI 50649111439757, Lot codes: SK-129, SK-130, SK-131; 2) 96-2237M, UDI/DI 50649111439764, Lot codes: SK-133; 3) 96-2238, UDI/DI 50649111439771, Lot codes: SK-131.

Distribution pattern: Domestic: Nationwide Distribution

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach of the sterile barrier