—#74930

Product

ReSolve Hydophilic Coated Locking Biliary Catheter, REF RBC-10-038, 10F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Used for drainage of bile within the biliary system.

FDA product code: FGE — Stents, Drains And Dilators For The Biliary Ducts
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K063733
Affected lot / code info: Lot numbers: G543416, G625227, MR604361, MR604362, MR604363, MR604364, and MR607895.

Why it was recalled

Biliary drainage catheter tips may separate from the catheter shaft after placement.

Root cause (FDA determination)

Other

Action the firm took

Customers were notified by Merit representatives by phone or visit beginning 11/07/2008. They were to identify and quarantine any unused inventory and complete a Product Retrieval Form. For further information, call 800-356-3748 x 4929.

Recalling firm

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

Distribution

Distribution pattern: Nationwide. OUS distribution to Canada, Colombia, France, Germany, Mexico, Ireland, Netherlands, South Korea, and UK.

Timeline

Recall initiated: 2008-11-07
Posted by FDA: 2009-01-13
Terminated: 2009-08-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74930. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.