FDA-Device2025-01-22Class II

ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery

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
25 units
Manufactured in
1333 Lenape Rd, West Chester, PA, United States
Products
ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0951-2025

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