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FDAFDA · Food and drugs·Recall number Z-0943-2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical biopsy

Published January 22, 2025 · Recall initiated: December 3, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Reports of various packaging issues that may result in a breach of the sterile barrier.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Sklar Instruments
Distributor
Domestic: Nationwide Distribution
Lot
1) 96-4113, UDI/DI 50649111492899, Lot codes: SK-133; 2) 96-4144A, UDI/DI 50649111492523, Lot codes: HSC21; 3) 96-4145A, UDI/DI 50649111492608, Lot codes: HSC21.
Risk classification
Class II
Area (FDA)
device
Country
United States

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