Z-0926-2025 Class II Ongoing
FDA device recall Z-0926-2025 was initiated by Sklar Instruments on Dec 3, 2024 and is designated Class II. Reason for recall: Reports of various packaging issues that may result in a breach of the sterile barrier. The recall status is ongoing. Affected quantity: 125 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 22, 2025
- Initiation Date
- Dec 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 125 units
Product Description
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)
Reason for Recall
Reports of various packaging issues that may result in a breach of the sterile barrier.
Distribution Pattern
Domestic: Nationwide Distribution
Code Information
1) 96-2483, UDI/DI 50649111449053, Lot codes: FSS5; 2) 96-2484, UDI/DI 50649111492950, Lot codes: SK-115