| Date Initiated by Firm | October 13, 2006 |
|---|
| Date Posted | November 14, 2006 |
|---|
| Recall Status1 |
Terminated 3 on December 04, 2007 |
| Recall Number | Z-0177-2007 |
|---|
| Recall Event ID |
36629 |
| 510(K)Number | K973645 |
|---|
| Product Classification |
Catheter - Product Code KRA
|
| Product | Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570 |
|---|
| Code Information |
Lot #: 7513978 |
| FEI Number |
2939204
|
Recalling Firm/
Manufacturer |
Boston Scientific Target
4701 Lakeview Blvd
Fremont
CA
94537
|
| For Additional Information Contact | Irene Jaworski
510-624-1580 |
|---|
Manufacturer Reason
for Recall | Incorrect expiration date: The product's exterior box date may be labeled with a longer than actual expiration date (the pouch label is correct) |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | On 10/6/06, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned. Product will be destroyed upon return. |
|---|
| Quantity in Commerce | 54 units |
|---|
| Distribution | Class III Recall-Worldwide-USA and Australia
|
|---|
| 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 = KRA
|
|---|
