Sklar Instruments: Device Recall
Recall #Z-0947-2025 · 12/03/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0947-2025
- 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 MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynecologic 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.