Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV Valve and 6.6F Silicone Catheter. Boston Scientifi
FDA device recall Z-0344-06 · posted 2006-01-06 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
- Action taken
- Boston Scientific letter dated 10/28/2005 sent via Federal Express. Customers (hospitals) instructed to remove and return product.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 97 units
- Distribution
- DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan
- Date initiated
- 2005-10-28
- Date posted
- 2006-01-06
- Date terminated
- 2007-02-15
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CATHETER INNOVATIONS IMPLANTABLE PORT (K991897) | Catheter Innovations, Inc. | 1999-10-21 |