Sklar Instruments: Device Recall
Recall #Z-0946-2025 · 12/03/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0946-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Sklar Instruments
- Status
- Ongoing
- Date Initiated
- 12/03/2024
- Location
- West Chester, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 units
Reason for Recall
Reports of various packaging issues that may result in a breach of the sterile barrier.
Product Description
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
Distribution Pattern
Domestic: Nationwide Distribution
Other Recalls by Sklar Instruments
- Class II: Risk 12/03/2024
- Class II: Risk 12/03/2024
- Class II: Risk 12/03/2024
- Class II: Risk 12/03/2024
- Class II: Risk 12/03/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.