—#88568

Product

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 product code: FGE — Stents, Drains And Dilators For The Biliary Ducts
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K072720
Affected lot / code info: Lot Numbers: F727579A and IML4457A.

Why it was recalled

Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent.

Root cause (FDA determination)

Component change control

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 West Merit Parkway, South Jordan, Utah 84095

Distribution

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.

Timeline

Recall initiated: 2010-01-28
Posted by FDA: 2010-02-22
Terminated: 2010-04-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88568. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.