Vaxcel Plastic Low Profile Port (non-valved) chest port, with 6Fr Polyurethane Catheter, Catalog 45-333, Material #M0014
FDA device recall Z-0944-05 · posted 2005-06-30 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Potential for port housing separation after implantation.
- Action taken
- A recall package issued to direct accounts on 6/8/05. Hospitals are instructed to return product in inventory, notify physicians, evaluate patients and explant devices whenever possible.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLD
- Distribution
- Product shipped to 56 medical facilities throughout the U.S.
- Date initiated
- 2005-06-08
- Date posted
- 2005-06-30
- 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 |
|---|---|---|
| VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233 (K032600) | Boston Scientific Corp | 2003-09-09 |
| VAXCEL PORT, MODELS 45-336 AND 45-338 (K032375) | Boston Scientific Corp | 2003-08-19 |