| Date Initiated by Firm | February 10, 2004 |
|---|
| Date Posted | July 20, 2004 |
|---|
| Recall Status1 |
Terminated 3 on October 25, 2005 |
| Recall Number | Z-0733-04 |
|---|
| Recall Event ID |
28398 |
| 510(K)Number | K031844 |
|---|
| Product Classification |
Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
|
| Product | Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Low Profile PS port, Implantable Port System, Model # M001452380, Catalog #45-238 |
|---|
| Code Information |
791484, 791485 |
Recalling Firm/
Manufacturer |
Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
|
| For Additional Information Contact | Nancy Cutino
508-652-5066 |
|---|
Manufacturer Reason
for Recall | Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Letters dated 2/9/04 with instructions to return current inventory . Also included is information concerning implanted ports. |
|---|
| Quantity in Commerce | 199 |
|---|
| Distribution | Shipments were nationwide to 158 medical facilities nationwide. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = LJT
|
|---|
