Recall Z-0901-2014 ยท BWN Table And Attachments, Operating-Room
Merit Medical Systems, Inc.
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 radi
| Date | Jan 30, 2014 (initiated Dec 18, 2013) |
| Status | Terminated |
| 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 |
| Root cause | 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 |
| Quantity | 11 |
| Distribution | Worldwide Distribution - USA including NJ, TX, WV, MN, GA, and Internationally to Mexico and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.