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COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1

FDA Recall #Z-0955-2023 — Class II — November 23, 2022

Recall #Z-0955-2023 Date: November 23, 2022 Classification: Class II Status: Ongoing

Product Description

COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1

Reason for Recall

The product is labeled with the incorrect expiration date.

Recalling Firm

Covidien, LLC — Minneapolis, MN

Classification

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

Product Type

Devices

Product Quantity

21 units

Distribution

Foreign Distribution: Hong Kong

Code Information

UDI/DI (GTIN): 10884521825765, Lot Number: 520200

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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