FDA recall Z-1390-2025

Covidien · Class I · device

Product

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

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

Key facts

Status: Ongoing
Initiation date: 2025-02-26
Report date: 2025-04-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Boulder, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1390-2025