Recall Z-1312-04 ยท ---
Nellcor Puritan Bennett
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 Extensi
| Date | Aug 7, 2004 (initiated Jul 8, 2004) |
| Status | Terminated |
| Reason | Device component can become disconnected or dislodged, leading to ineffective ventilation, which could result in serious injury or death. |
| Root cause | Other |
| Action | 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.]*** . |
| Quantity | 71,021 units |
| Distribution | The tracheostomy tubes were distributed to 4,179 direct US and US Territory customers. The firm has also distributed products to Canada, the UK, Latin America and Japan. The firm's branches in those countries are handling the recall activities in those countries. The firm manufactured 95,923 unit |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003315 | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA Mallinckrodt, Inc., Nov 8, 2000 |