Recall Z-0721-05 ยท JDH Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
Nellcor Puritan Bennett
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 Uncuffe
| Date | Apr 22, 2005 (initiated Dec 9, 2004) |
| Status | Terminated |
| Reason | Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury. |
| Root cause | Other |
| Action | 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. |
| Quantity | 323 units shipped to US Field Personnel or Healthcare facilities. |
| Distribution | The firm has indicated that product was released for distribution to 7 consignees in US and to 17 foreign countries via international distribution centers. The firm has indicated that a very limited number of the product was distributed in the US to selected facilities that were participating in cu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030787 | SHILEY FLEXTRA TRACHEOSTOMY TUBE Nellcor Puritan Bennett, Inc., Nov 14, 2003 |