Medical Device Recall: Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Covidien · February 26, 2025
Reason for Recall
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.
Distribution
OUS distribution only to countries of: France, Germany, Ireland, Italy, Lithuania, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Taiwan
Quantity Affected
780
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1390-2025
Status: ongoing
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