| |
Class 2 Device Recall Matrix2 |
 |
| Date Initiated by Firm |
February 07, 2007 |
| Date Posted |
March 29, 2007 |
| Recall Status1 |
Terminated 3 on November 27, 2007 |
| Recall Number |
Z-0668-2007 |
| Recall Event ID |
37384 |
| 510(K)Number |
K050700
|
| Product Classification |
vascular embolization device - Product Code HCG
|
| Product |
Matrix2 Detachable Coils, vascular embolization device.
Catalog Number: 497204SR, UPN: M003497204SR0,
Catalog Number: 494203, UPN: M0034942030, Distributed and Manufactured by Boston Scientific Corporation, Neurovascular Division, Fremont, CA |
| Code Information |
Batch Numbers: 8941830 and 8852539 |
Recalling Firm/
Manufacturer |
Boston Scientific Target
47900 Bayside Pkwy
Fremont CA 94538-6515
|
Manufacturer Reason
for Recall |
The product may be missing the temperature indicator label on the inner pouch.
|
FDA Determined
Cause 2 |
Other |
| Action |
The firm initiated the recall on 02/07/2007, and initially notified consignees via letter. |
| Quantity in Commerce |
57 units |
| Distribution |
Worldwide including USA, Argentina, Australia, Brazil, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Netherlands, and New Zealand. |
| 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 = HCG and Original Applicant = BOSTON SCIENTIFIC CORP.
|
|
|
|
