Merit Medical Systems, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0866-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.

Product Classification:

Class II

Date Initiated: January 16, 2013

Date Posted: February 27, 2013

Recall Number: Z-0866-2013

Event ID: 64202

Reason for Recall:

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

Status: Terminated

Product Quantity: 387 units

Code Information:

Lot numbers H399931S1; H411376; H399938S1; H411373; H399940S1; H411374; H399942S1; H411375; H399948S1; H411380; H399950S1; H411377; H39952S1; H411378; H39953S1; H411379.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated