Events

Recall of Device Recall ReSolve Locking Drainage Catheters

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Merit Medical Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71694
  • Event Risk Class
    Class 2
  • Event Number
    Z-2352-2015
  • Event Initiated Date
    2015-06-29
  • Event Date Posted
    2015-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138760
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, continuous irrigation - Product Code GBQ
  • Reason
    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.
  • Action
    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.

Device

Device Recall ReSolve Locking Drainage Catheters
  • Model / Serial
    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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the Virgin Islands.
  • Product Description
    ReSolve Locking Drainage Catheters || The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Manufacturer Address
    Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
  • Manufacturer Parent Company (2017)
    Merit Medical Systems Inc
  • Source
    USFDA