| Date Initiated by Firm |
June 23, 2003 |
| Date Posted |
July 19, 2003 |
| Recall Status1 |
Terminated 3 on October 03, 2018 |
| Recall Number |
Z-1033-03 |
| Recall Event ID |
26601 |
| 510(K)Number |
K955293
|
| Product |
Fibered Platinum Coil, 0.035 Type,
4 mm x 30 mm
Catalog no. 372403 |
| Code Information |
Lot Number: 5473831 |
Recalling Firm/
Manufacturer |
Boston Scientific Corporation
1 Boston Scientific Place
Natick MA 01760
|
| For Additional Information Contact |
Arthur Friedman
508-652-5085
|
Manufacturer Reason
for Recall |
Product 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa
|
FDA Determined
Cause 2 |
Other |
| Action |
Boston Scientific notified sales representatives on 6/23/03 in foreign distribution area to remove product from inventory and contact hospital to retrieve and return. |
| Quantity in Commerce |
30 units |
| Distribution |
Japan, Italy, France, Turkey, Israel, Finland |
|
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 = and Original Applicant = TARGET THERAPEUTICS
|
