Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- January 16, 2013
- Posted
- February 20, 2013
- Terminated
- September 16, 2015
- Recall Number
- Z-0866-2013
- Quantity
- 387 units
- Firm Location
- South Jordan, UT
Reason for Recall
A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
Distribution
Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark
Lot / Code Info
Lot numbers H399931S1; H411376; H399938S1; H411373; H399940S1; H411374; H399942S1; H411375; H399948S1; H411380; H399950S1; H411377; H39952S1; H411378; H39953S1; H411379.
Root Cause
Nonconforming Material/Component
Action Taken
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,