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U.S. Department of Health and Human Services

Class 2 Device Recall Endotek AlimaxxB Uncovered Biliary Stent

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  Class 2 Device Recall Endotek AlimaxxB Uncovered Biliary Stent see related information
Date Initiated by Firm January 28, 2010
Date Posted February 22, 2010
Recall Status1 Terminated 3 on April 27, 2010
Recall Number Z-0804-2010
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 70129-208, 10 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: F727581A, IML4481A and IML4482A.
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 16 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 and Original Applicant = ALVEOLUS, INC.
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