Shiley Adult Flexible Tracheostomy Tubes Recalled Due to Undersized Connectors
Covidien is recalling Shiley Adult Flexible Tracheostomy Tubes due to undersized connectors that create loose connections with 15mm respiratory circuit components. Unsecure connections could cause respiratory failure, difficulty breathing, treatment delays, or serious injury.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4. The manufacturing defect creates a risk of respiratory failure, difficulty breathing, and tissue injury through unsecure connections, though no incidents have been reported to date.
Plain-English summary
Covidien is recalling Shiley Adult Flexible Tracheostomy Tubes due to a manufacturing error. The tube connectors are smaller in diameter than specified, creating unsecure connections with 15mm caps and other 15mm circuit components and accessories used in respiratory care.
An unsecure connection could lead to respiratory failure, difficulty breathing, treatment delay, tissue injury, or bleeding.
The recall affects 599,187 units in multiple sizes (6.5mm to 10.0mm) and configurations, distributed worldwide. Both cuffed and cuffless tube types, with disposable or reusable inner cannulas, are included in the recall.
Patients and healthcare facilities should check lot numbers against the official FDA recall notice and contact Covidien if they have affected tubes in use. Healthcare providers should discuss appropriate next steps with their patients.
The recalled product
- Product
- Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description): 10CN10H, 10.0MM SHILEY CUFFED TRACH CAN; 10CN10R, 10.0MM ADT FLEX TRACH W TG CUFF; 10UN10A, 10.0MM UNCUFF TRACH TUBE X1…
- Manufacturer
- Covidien
- Affected units
- 599,187
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UDI-DI/Lot: 10CN10H/10884521172371/21C0402JZX
- 21D0461JZX
- 21G0457JZX
- 21I0293JZX
- 21I0294JZX
- 21I0552JZX
- 21J1435JZX
- 21J1436JZX
- 21K0275JZX
- 21K0276JZX
- 21K0277JZX
- 21K0278JZX
- 10CN10R/10884521205475/202107218X
- 202107296X
- 202108128X
- 202108285X
- 21H0792JZX
- 21H0793JZX
- 21H0794JZX
- 22I0596JZX
Distribution
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