Sheridan Sher-I-Bronch Endobronchial Tube for Right Bronchial Intubation; an Rx, sterile, sinlge use endobronchial tube
FDA device recall Z-0681-05 · posted 2005-04-06 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating 'Bronchial - Right' instead of 'Bronchial - Left', and catalog number 5-16137 stating 'Bronchial - Left' instead of 'Bronchial - Right'.
- Action taken
- Customers were notified via Federal Express, Next Business Day Delivery, on February 23, 2005. The accounts were informed of the mislabeling and were instructed to inspect the product lots for any incorrectly printed devices, comparing the writing on the sleeve of the blue bronchial tube with the package label which is correct, and to return all identified affected product to Teleflex Medical, Hudson RCI.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBI
- Distribution
- Nationwide and internationally to Argentina, Canada, Chile, China, Costa Rica, Hong Kong, Korea, the Netherlands, South Africa and Vietnam.
- Date initiated
- 2005-02-23
- Date posted
- 2005-04-06
- Date terminated
- 2006-07-31
- Location
- Bannockburn, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE (K851856) | Sheridan Catheter Corp. | 1985-05-23 |