ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER C...
FDA Recall #Z-0932-2025 — Class II — December 3, 2024
Product Description
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO STERILE NAIL NIPPER FLD SPRG 4.5STER25, Model Number 96-2666A; 5) ECONO STERILE NAIL NIPPER 4 1/2" STERILE 50, Model Number 96-2667; 6) ECONO STERILE NAIL NIPPER BRL SPRG 5.5STER25, Model Number 96-2671A; nail 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
7730 units
Distribution
Domestic: Nationwide Distribution
Code Information
1) 96-2424A, UDI/DI 50649111484504, Lot codes: SK-112; 2) 96-2427, UDI/DI 50649111449008, Lot codes: SK-131; 3) 96-2666, UDI/DI 50649111078918, Lot codes: SK-118; 4) 96-2666A, UDI/DI 50649111488120, Lot codes: SK-112, SK-118; 5) 96-2667, UDI/DI 50649111079090, Lot codes: SK-118; 6) 96-2671A, UDI/DI 50649111488113, Lot codes: SK-112.
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.