FDA-Device2025-01-22Class II

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

Sklar Instruments
Hazard

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

Sold states
Domestic: Nationwide Distribution
Affected count
175 units
Manufactured in
1333 Lenape Rd, West Chester, PA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0930-2025

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