Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed; 358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 358100, Size 10, FlexTra Cuffed; 359060, Size 6, FlexTra Uncuffed; 359070, Size 7, FlexTra Uncuffed; 359080, Size 8, FlexTra Uncuffed; 359090, Size 9, FlexTra Uncuffed; 359100, Size 10, FlexTra Uncuffed, Tyco Healthcare/Nellcor is currently responsible for Research and Development for this product.
Hazard
Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury.
What You Should Do
Remedy
On 12/3/04, the firm issued letters to all its international consignees, informing them of the affected product and providing instructions on the recall.
Affected by this recall?
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Products
Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube,
Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed;
358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 3
- Brand
- Nellcor Puritan Bennett
- UPC
- All codes are affected.
Units Affected
323 units shipped to US Field Personnel or Healthcare facilities.