Shiley TracheoSoft XLT Extended Length Tracheostomy tube; Model Numbers: 72110-050, size 5, Proximal Extension, Uncuffed; 72110-060, size 6, Proximal Extension, Uncuffed; 72110-070, size 7, Proximal Extension, Uncuffed; 72110-080, size 8, Proximal Extension, Uncuffed; 72120-050, size 5, Promixal Extension, Cuffed; 72120-060, size 6, Promixal Extension, Cuffed; 72120-070, size 7, Promixal Extension, Cuffed; 72120-080, size 8, Promixal Extension, Cuffed; 73110-050, size 5, Distal Extension, Uncu
Hazard
Device component can become disconnected or dislodged, leading to ineffective ventilation, which could result in serious injury or death.
What You Should Do
Remedy
On 7/8/04, the firm initiated the recall. ***[After CDRH recommendations for class I recall situation, the firm issued PR via AP on 8/6/04.]*** .
Affected by this recall?
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Products
Shiley TracheoSoft XLT Extended Length Tracheostomy tube;
Model Numbers:
72110-050, size 5, Proximal Extension, Uncuffed;
72110-060, size 6, Proximal Extension, Uncuffed;
72110-070, size 7, Proximal
- Brand
- Nellcor Puritan Bennett
- UPC
- All units of these models.
Units Affected
71,021 units