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EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)

FDA Recall #Z-0985-2025 — Class II — December 12, 2024

Recall #Z-0985-2025 Date: December 12, 2024 Classification: Class II Status: Ongoing

Product Description

EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)

Reason for Recall

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

Recalling Firm

Medtronic Perfusion Systems — Brooklyn Park, MN

Classification

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

Product Type

Devices

Product Quantity

930 units

Distribution

Worldwide - US Nationwide distribution.

Code Information

Model 77418 UDI-DI: 20763000135618, Lot Numbers: 2022041038; Model 77422 UDI-DI: 20643169485970, Lot Number: 2023020934

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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