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Covidien Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R - safety alert

Official notice

2 Apr 2025

CriticalFDA

An official FDA notice concerns Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R. The notice reports an infection risk. Stop using the product and follow the official notice. Published 2025-04-02. Recall numbers: Z-1390-2025. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

780

Recall number

Z-1390-2025

Official notice

2025-04-02

The hazard

Infection 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.

Other

UDI-DI 8845212054401

Event Ids

96371

Recall Numbers

Z-1390-2025

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Affected products

Product 1

Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R

Units affected

780

Risk / hazard

Infection 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

DE · Germany

Affected area 3

ES · Spain

Affected area 4

FR · France

Affected area 5

IE · Ireland

Affected area 6

IT · Italy

Affected area 7

LT · Lithuania

Affected area 8

PT · Portugal

Affected area 9

SA · Saudi Arabia

Affected area 10

SI · Slovenia

Affected area 11

SK · Slovakia

Affected area 12

TW · Taiwan

Affected area 13

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Covidien. Contact: Covidien.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class I

App estimate

critical

Recall details

Recall number

Z-1390-2025

Event id

96371

Units affected

780

Status

active

Classification

Class I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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