| Date Initiated by Firm | March 14, 2007 |
|---|
| Date Posted | April 11, 2007 |
|---|
| Recall Status1 |
Terminated 3 on May 15, 2007 |
| Recall Number | Z-0730-2007 |
|---|
| Recall Event ID |
37628 |
| 510(K)Number | K031186 |
|---|
| Product Classification |
Endoscopic Biliary Stent, - Product Code FGE
|
| Product | Flexxus™ Endoscopic Biliary Stent, 7.5 Fr
10 mm diameter x 60 mm length
Item Number: LXB10060 |
|---|
| Code Information |
Lot Number: ANQJ0639 |
Recalling Firm/
Manufacturer |
Conmed Endoscopic Technologies, Inc.
129 Concord Rd Bldg 3
Billerica MA 01821-4600
|
| For Additional Information Contact | Beth Zis
978-964-4251 |
|---|
Manufacturer Reason
for Recall | Blue safety clip incorrectly placed on the stent may prevent deployment |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | ConMed Endoscopic Technologies notified consignes by letter dated 3/14/07 requesting them to return recalled devices. |
|---|
| Quantity in Commerce | 1 UNIT |
|---|
| Distribution | Worldwide distribution, USA including states of DE, OH, MI, DC and countries of Belgium Japan. |
|---|
| 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 = FGE
|
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