Sklar Instruments Recall 95946
Description: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; general purpose clips
Sklar Instruments Recall 95946 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0936-2025 |
| Event ID | 95946 |
| Event Description | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; general purpose clips |
| Product Type | Devices |
| Distribution | Domestic: Nationwide Distribution |
| Quantity | 300 units |
| Recall Reason | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| Device Classification | 20250122 |
| Device Code Info | 1) 96-2630, UDI/DI 50649111072350, Lot codes: SK-128, SK-129; 2) 96-2636, UDI/DI 50649111073524, Lot codes: FSF14. |
| Center Classification Date | 20250116 |
| Recall Initiation Date | 20241203 |
| Recalling Firm | Sklar Instruments |
| Initial Notification | Letter |
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