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ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS...

FDA Recall #Z-0947-2025 — Class II — December 3, 2024

Recall #Z-0947-2025 Date: December 3, 2024 Classification: Class II Status: Ongoing

Product Description

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynecologic biopsy

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

0 units

Distribution

Domestic: Nationwide Distribution

Code Information

1) 96-4134M, UDI/DI 50649111492547, Lot codes: SK-114; 2) 96-4137M, UDI/DI 50649111492530, Lot codes: SK-116.

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.

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