| Class 2 Device Recall Endotek AlimaxxB Uncovered Biliary Stent | |
Date Initiated by Firm | January 28, 2010 |
Date Posted | February 22, 2010 |
Recall Status1 |
Terminated 3 on April 27, 2010 |
Recall Number | Z-0801-2010 |
Recall Event ID |
54485 |
510(K)Number | K072720 |
Product Classification |
Catheter, biliary, diagnostic - Product Code FGE
|
Product | Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-204, 8 x 40, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Intended for palliation of malignant neoplasms in the biliary tree. |
Code Information |
Lot Numbers: F727578A and IML4466A. |
Recalling Firm/ Manufacturer |
Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan UT 84095
|
For Additional Information Contact | 801-316-4932 |
Manufacturer Reason for Recall | Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent. |
FDA Determined Cause 2 | Component change control |
Action | Merit Medical Systems, Inc initiated customer notification by phone and letter beginning January 28, 2010. Consignees were instructed to immediately contact their affected customers, advise them of the recall activity and to identify and quarantine any unused inventory. A Recall Notification Form is to be completed and signed by the sales rep and by the site representative. Affected product is to returned to the firm.
For further information, contact Merit Medical Systems, Inc. at 1-801-208-4228. |
Quantity in Commerce | 6 units |
Distribution | Nationwide Distribution -- AL, CA, CO, FL, IL, KY, NY, MA, MD, ME, MN, MO, PA, TX, UT, VA, WI, VA, TX and WI. |
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
|
|
|
|