Z-1390-2025 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 2, 2025
- Initiation Date
- February 26, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 780
Product Description
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 Pattern
OUS distribution only to countries of: France, Germany, Ireland, Italy, Lithuania, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Taiwan
Code Information
UDI-DI/GTIN: A8845212054401, 20884521205441, 10884521205444. Lot: 202405258X. Expiration: 06/01/2029