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Sklar Instruments recalls ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960;
Recalled January 22, 2025 · FDA recall Z-0946-2025 · Sklar Instruments
Hazard
Reports of various packaging issues that may result in a breach of the sterile barrier. · FDA Class II
Units
75 units
Sold at
Domestic: Nationwide Distribution
Description
Reports of various packaging issues that may result in a breach of the sterile barrier.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE HEGAR DILATOR 5&6MM STERL CS25Model Number 96-0963; 5) ECONO STERILE HEGAR DILATOR 3&4MM STERL CS25Model Number 96-0964; 6) ECONO STERILE HEGAR DILATOR 1&2MM STERL CS25Model Number 96-0965; 7) ECONO STERILE HANK DILATOR 5.5&6MM STRL CS25Model Number 96-0966; gynecological dilators
Manufacturer(s)
Sklar Instruments
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →