| Date Initiated by Firm | August 10, 2005 |
|---|
| Date Posted | November 01, 2006 |
|---|
| Recall Status1 |
Terminated 3 on May 16, 2012 |
| Recall Number | Z-0122-2007 |
|---|
| Recall Event ID |
36507 |
| 510(K)Number | K000177 |
|---|
| Product Classification |
microcatheter - Product Code KRA
|
| Product | Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990 |
|---|
| Code Information |
Lot Number: 7552069 |
| FEI Number |
3001451463
|
Recalling Firm/
Manufacturer |
Boston Scientific Corporation
One Boston Scientific Place
Natick
MA
01760-1536
|
| For Additional Information Contact | Robert T. Miragliuolo
508-683-4186 |
|---|
Manufacturer Reason
for Recall | Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04 |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Recall notification packages including a Reply Verification Tracking Form were sent to Boston Scientific representatives via Fed Ex on 8/10/2005. Boston Scientific representatives delivered the packages to the consignees. The Consignees were instructed to return affected product to Boston Scientific to be relabeled. |
|---|
| Quantity in Commerce | 5 units |
|---|
| Distribution | TX, KY |
|---|
| 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
|
|---|
