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ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, ...

FDA Recall #Z-0834-2024 — Class II — December 11, 2023

Recall #Z-0834-2024 Date: December 11, 2023 Classification: Class II Status: Ongoing

Product Description

ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W

Reason for Recall

There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.

Recalling Firm

Ethicon Endo-Surgery Inc — Blue Ash, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

22,616 (US), 4,476 (OUS)

Distribution

Worldwide distribution - US Nationwide and the countries of Canada and Brazil.

Code Information

UDI-DI 10705036014928 Lots 442C02 and 442C03

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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