No image published for this recall

No image published for this recall

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

Official notice

2 Apr 2025

Last checked

2 Apr 2025

Critical riskFDA

An official FDA notice concerns Covidien Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R - safety alert. 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. Published 2025-04-02.

What to do now

The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.

Units affected

780

Recall number

Z-1390-2025

Official notice

2025-04-02

The hazard

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.

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

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.

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 · CO · Boulder

Affected area 1

US · United States · CO · Boulder

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Covidien. Contact: Covidien.

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

critical

Recall details

Recall number

Z-1390-2025

Event id

96371

Units affected

780

Status

active

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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