FDA-Device2025-04-02Class I
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Covidien
Hazard
Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.
Sold states
OUS distribution only to countries of: France, Germany, Ireland, Italy, Lithuania, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Taiwan
Affected count
780
Manufactured in
6135 Gunbarrel Ave, N/A, Boulder, CO, United States
Products
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1390-2025Don't want to check this manually?
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