Recall Z-1673-2014 ยท FRN Pump, Infusion
Bayer Corp
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outs
| Date | May 30, 2014 (initiated Apr 3, 2014) |
| Status | Terminated |
| Reason | There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008. |
| Root cause | Component design/selection |
| Action | Bayer sent an Urgent Medical Device Recall and Removal Letters dated April 3, 2014, and April 30, 2014, were sent to direct accounts to notify them of the bracket issue and to provide additional instructions for testing and/or returning the brackets. As a critical medical needs site currently using Continuum with a recalled bracket you have two options: 1. Immediately return your Continuum(s) for refund. 2. Take actions to ensure continued safe use of your system associated with the bracket recall. You will still be eligible for a refund when you return the system no later than June 30, 2015. |
| Quantity | 1347 |
| Distribution | Worldwide Distribution - USA (nationwide) including the countries of Australia, Brazil, Belgium, Canada, Germany, Singapore, South Africa, Poland, Mexico and UAE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073051 | MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY Medrad, Inc., May 30, 2008 |