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Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1 - safety alert

Official notice

17 Nov 2021

CriticalFDA

An official FDA notice concerns Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1. The notice reports a fire or burn risk. Follow the official notice for consumer instructions. Published 2021-11-17. Lots: 516840. Recall numbers: Z-0210-2022. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

14

Recall number

Z-0210-2022

Official notice

2021-11-17

The hazard

Fire or burn risk

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

516840

Event Ids

88817

Recall Numbers

Z-0210-2022

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Affected products

Product 1

Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

Units affected

14

Risk / hazard

Fire or burn risk

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

GB · United Kingdom

Affected area 3

HK · Hong Kong

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Covidien. Contact: Covidien Llc.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

critical

Recall details

Recall number

Z-0210-2022

Event id

88817

Units affected

14

Status

terminated

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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