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U.S. Department of Health and Human Services

Class 2 Device Recall Merit RAD BOARD

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  Class 2 Device Recall Merit RAD BOARD see related information
Date Initiated by Firm December 18, 2013
Date Posted January 30, 2014
Recall Status1 Terminated 3 on February 13, 2014
Recall Number Z-0901-2014
Recall Event ID 67206
Product Classification Table and attachments, operating-room - Product Code BWN
Product 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.
Code Information lot B507171
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan UT 84095
For Additional Information Contact Paul Kennedy
801-208-4301
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 Labeling Change Control
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 Merit requests that customers stop using these devices immediately until the product has been replaced by their Merit sales representative.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.
Quantity in Commerce 11
Distribution Worldwide Distribution - USA including NJ, TX, WV, MN, GA, and Internationally to Mexico and Japan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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