Sklar Instruments: Device Recall
Recall #Z-0943-2025 · 12/03/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0943-2025
- 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
- 0 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 SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical biopsy
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.