—#115545

Product

Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, 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: K121832
Affected lot / code info: Lot numbers H399931S1; H411376; H399938S1; H411373; H399940S1; H411374; H399942S1; H411375; H399948S1; H411380; H399950S1; H411377; H39952S1; H411378; H39953S1; H411379.

Why it was recalled

A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Merit initiated the recall on January 16, 2013. A voicemail script notification to users and Q&A document was provided to those sales representative that had received and or distributed product. On January 16, 2013, Merit sales representatives began contacting each physician and/or user facility that had been provided product. Written communication distribution began on 22 January 2013. Affected sales representatives, physicians, and hospitals were provided written identification information, instruction to not distribute or continue placing these devices, and on how to return any unused product if applicable. All product on hand at Merit was inventoried and remains under quarantined status. Further questions please call (801) 208-4301,

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark

Timeline

Recall initiated: 2013-01-16
Posted by FDA: 2013-02-20
Terminated: 2015-09-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115545. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.