Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD Re-Entry Catheter is indicated for pla
FDA device recall Z-0279-2009 · posted 2008-10-31 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- The Cordis LuMend Outback LTD Re-Entry Catheter - separation rate of the cannula to the deployment slide of the handle assembly is higher than anticipated. The cannula is unable to be retracted into the device after deployment due to a separation of the inner key from the cannula.
- Action taken
- U.S. Customers - A Notification of Recall Letter with an Acknowledgement Form was sent overnight to 5 individuals in each account on 08/18/2008. For non-U.S. customers, email notification with return acknowledgement is used to notify the affiliate distributors, who then notify and reconcile the customers in those countries (08/18/2008). Contact Cordis special Customer Service at (800) 551-7683 for assistance.
- Root cause
- Other
- Status
- Terminated
- Product code
- MCW
- Quantity affected
- 11,893
- Distribution
- Worldwide
- Date initiated
- 2008-08-20
- Date posted
- 2008-10-31
- Date terminated
- 2008-12-01
- Location
- Miami Lakes, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO OUTBACK CATHETER (K043534) | Lumend, Inc. | 2005-01-21 |
| MODIFICATION TO OUTBACK CATHETER (K040771) | Lumend, Inc. | 2004-04-23 |
| MODIFICATION TO OUTBACK CATHETER (K032298) | Lumend, Inc. | 2003-08-26 |
| MODIFICATION TO OUTBACK CATHETER (K014117) | Lumend, Inc. | 2002-01-11 |
| OUTBACK CATHETER (K001577) | Lumend, Inc. | 2001-01-11 |