Shiley TracheoSoft XLT Extended Length Tracheostomy tube; Model Numbers: 72110-050, size 5, Proximal Extension, Uncuffed
FDA device recall Z-1312-04 · posted 2004-08-07 · Terminated
Recall details
- Recalling firm
- Nellcor Puritan Bennett
- Reason for recall
- Device component can become disconnected or dislodged, leading to ineffective ventilation, which could result in serious injury or death.
- Action taken
- 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.]*** .
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 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 c
- Date initiated
- 2004-07-08
- Date posted
- 2004-08-07
- Date terminated
- 2005-11-29
- Location
- Pleasanton, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (K003315) | Mallinckrodt, Inc. | 2000-11-08 |