| Date Initiated by Firm | June 24, 2004 |
|---|
| Date Posted | July 20, 2005 |
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| Recall Status1 |
Terminated 3 on July 21, 2005 |
| Recall Number | Z-1021-05 |
|---|
| Recall Event ID |
32286 |
| 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. |
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| 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.
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