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

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.

Details from the source

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: 780 Lot/code info: UDI-DI/GTIN: A8845212054401, 20884521205441, 10884521205444. Lot: 202405258X. Expiration: 06/01/2029

UPC codes

20884521205441, 10884521205444

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.