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ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, ...

FDA Recall #Z-0945-2025 — Class II — December 3, 2024

Recall #Z-0945-2025 Date: December 3, 2024 Classification: Class II Status: Ongoing

Product Description

ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological 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

40 units

Distribution

Domestic: Nationwide Distribution

Code Information

96-4142A, UDI/DI 50649111488014, Lot Codes: HSI

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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