Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080
FDA device recall Z-0714-06 · posted 2006-04-06 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm
- Action taken
- Smiths Medical ASD, Inc. notified US customers by letter dated 3/7/06. Accounts are requested to return inventory.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTO
- Quantity affected
- 5350 units (107 cases)
- Distribution
- Nationwide
- Date initiated
- 2006-03-07
- Date posted
- 2006-04-06
- Date terminated
- 2012-05-08
- Location
- Keene, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA (K030381) | Portex , Ltd. | 2003-08-27 |