Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-205, 8 x 60, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for palliation of malignant neoplasms in the biliary tree.
FDA Recall Z-0802-2010 · Posted 2010-02-22
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Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeFGE
Date Initiated2010-01-28
Date Terminated2010-04-27
Product Quantity15 units
Reason for Recall
Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent.
Firm 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.
Root Cause
Component change control
Distribution Pattern
Nationwide Distribution -- AL, CA, CO, FL, IL, KY, NY, MA, MD, ME, MN, MO, PA, TX, UT, VA, WI, VA, TX and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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