Sklar Instruments: Device Recall
Recall #Z-0950-2025 · 12/03/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0950-2025
- 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
- 350 units
Reason for Recall
Reports of various packaging issues that may result in a breach of the sterile barrier.
Product Description
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISMUS SCISS STR4.5"CS/25, Model Number 96-2542M; eye surgery
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.