| Date Initiated by Firm | March 17, 2003 |
|---|
| Date Posted | April 17, 2003 |
|---|
| Recall Status1 |
Terminated 3 on March 07, 2016 |
| Recall Number | Z-0739-03 |
|---|
| Recall Event ID |
25812 |
| 510(K)Number | K870694 |
|---|
| Product Classification |
Catheter, Urethral - Product Code GBM
|
| Product | Boston Scientific/Microvasive Cone Tip Ureteral Catheter (7 Fr x 70 cm)
Product Number: 400-213 |
|---|
| Code Information |
Lot Numbers: 5218586 5218586 5303655 5312172 5348155 |
| FEI Number |
3001451463
|
Recalling Firm/
Manufacturer |
Boston Scientific Corporation
1 Boston Scientific Place
Natick MA 01760
|
| For Additional Information Contact | Robert T. Miragliulo
508-652-5186 |
|---|
Manufacturer Reason
for Recall | Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Boston Scientific/Microvasive, Natick, MA notified domestic accounts by letter on 3/17/03. Users are requesed to check inventory and return product to Boston Scientific. A responsed form was requested to be completed. and returned by facsmile. |
|---|
| Quantity in Commerce | 6 boxes (20 units/box) |
|---|
| Distribution | Nationwide
Foreign:Singapore, Japan, Korea, Canada, Africa |
|---|
| 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 = GBM
|
|---|
