Vaxcel Low Profile Port with PASV Valve and 6F Polyurethane Catheter. CATALOG NO. 45-233. Ref. # M001452330. FIRM ON LAB
FDA device recall Z-0780-05 · posted 2005-04-28 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Potential separation of the port base from the port cover after implantation.
- Action taken
- Letters sent 3/11/2005 via Federal Express to hospitals receiving affected product. Customers instructed to remove/return product, notify physicians, evaluate patients and explant devices whenever possible.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLD
- Quantity affected
- 160 units
- Distribution
- 1215 units shipped to 123 hospitals throughout the U.S. 2 units shipped to Boston Scientific in South Africa where 1 unit had been used as a demo (non-human use) and 1 units is in BSC control
- Date initiated
- 2005-02-25
- Date posted
- 2005-04-28
- Date terminated
- 2006-08-09
- 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 |