| Date Initiated by Firm |
June 24, 2004 |
| Date Posted |
July 20, 2005 |
| Recall Status1 |
Terminated 3 on July 21, 2005 |
| Recall Number |
Z-1021-05 |
| Recall Event ID |
32286 |
| 510(K)Number |
K9805040
|
| Product Classification |
Introducer, Catheter - Product Code DYB
|
| Product |
EMCEE OBTURATOR (7F) for use with 8F Sheath, REF #92580008, packaged in individual labeled pouches, 10 units per box, 40 boxes per case. Firm on label: Schneider/NAMIC, Glens Falls, New York 12801 |
| Code Information |
884421 exp 05/2006; 885027 exp 05/2006; 937757 exp. 01/2007. |
Recalling Firm/
Manufacturer |
Boston Scientific Corp
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
|
| For Additional Information Contact |
Michael Duerr
518-742-4571
|
Manufacturer Reason
for Recall |
Product labeled to contain Emcee Obturators contained Emcee Dilators.
|
FDA Determined
Cause 2 |
Other |
| Action |
Phone calls to one consignee on 6/24/2004 and the 2nd U.S. consignee on 6/30/2004. The foreign consignee was notified via mail on 10/18/2004. |
| Quantity in Commerce |
90 units |
| Distribution |
Domestic: Two consignees in NJ and IN. Foreign: One consignee in Belgium. |
| 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.
|
