—#138760

Product

ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.

FDA product code: GBQ — Catheter, Continuous Irrigation
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot No: E796578 E796579 MR792035 MR786325 MR797946 MR791206 MR791212 MR786923 E796605 MR786311 MR791660 E796647 RL MR795466 MR786301 E796629 E796631 E796636 E796637 MR786306 MR786320 MR786318 MR786319

Why it was recalled

Merit Medical Systems, Inc. is voluntarily conducting a recall due to a potential discrepancy between the unit labeling of the Merit ReSolve Drainage Catheters and the actual device in the package.

Root cause (FDA determination)

Employee error

Action the firm took

Merit Medical Systems sent an Urgent Product Recall Notice dated July 10, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions required of you: 1. Please immediately determine if any of the devices are within your facility, quarantine them, and discontinue use. Due to the nature of this label discrepancy, you will need to physically verify whether product in inventory is within the scope of this recall. Your Merit Sales Representative can assist you with this determination. 2. Ensure that all personnel to whom the devices were distributed are made aware of this field action. 3. Please work with your Merit Sales Representative to arrange product return. 4. If you have any questions concerning this communication, please don't hesitate to contact your Merit Sales Representative or call (801)208-4365.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution including the Virgin Islands.

Timeline

Recall initiated: 2015-06-29
Posted by FDA: 2015-08-07
Terminated: 2015-10-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138760. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.