Events

Recall of Device Recall Merit RAD BOARD

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
    67206
  • Event Risk Class
    Class 2
  • Event Number
    Z-0901-2014
  • Event Initiated Date
    2013-12-18
  • Event Date Posted
    2014-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124977
  • 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
    Table and attachments, operating-room - Product Code BWN
  • Reason
    Merit medical systems, inc. is voluntarily recalling one lot (b507171) of rad board rb 100 devices. the affected devices are missing the main label which graphically depicts patient orientation on the board. the issue may allow the board to be oriented in the wrong direction where the semi-radiopaque material in the board (embedded xenolite) could obscure patient anatomy during fluoroscopy. there.
  • Action
    Merit Medical Systems, Inc.sent a letter voluntarily recalling one lot (B507171) of RAD BOARD" RB100 devices. The affected devices are missing the main label which graphically depicts patient orientation on the board. The issue may allow the board to be oriented in the wrong direction where the semi-radiopaque material in the board (embedded Xenolite) could obscure patient anatomy during fluoroscopy. There have been no reports of patient harm or injury from Merit customers as a result of this issue. Merit has chosen to remove this lot from the field by replacing the unlabeled RAD BOARDs. Merit requests that customers stop using these devices immediately until the product has been replaced by their Merit sales representative. Customers with questions were instructed to call 1-801-208-4344 or 1-801-208-4365. For questions regarding this recall call 801-208-4301.

Device

Device Recall Merit RAD BOARD
  • Model / Serial
    lot B507171
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including NJ, TX, WV, MN, GA, and Internationally to Mexico and Japan.
  • Product Description
    Radial Assist RAD BOARD, used to support the || weight of a patient's arm and supplies for a medical procedure. || The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical purposes. RAD BOARD was specifically designed to support the weight of a patient's arm and supplies for medical procedure, in order to have optimal access to upper extremity vasculature, including radial and brachial arterial and venous access. The RAD BOARD is partially lined with a layer of lead-free Xenolite TB for additional radiation scatter protection.
  • 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