ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25...
FDA Recall #Z-0926-2025 — Class II — December 3, 2024
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.
Recalling Firm
Sklar Instruments — West Chester, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
125 units
Distribution
Domestic: Nationwide Distribution
Code Information
1) 96-2483, UDI/DI 50649111449053, Lot codes: FSS5; 2) 96-2484, UDI/DI 50649111492950, Lot codes: SK-115
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.