FDA Device recall Z-1673-2014
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medic…
- FDA Device
- Class II
- terminated
- Published 2014-06-11
On 2014-06-11 the FDA classified a Class II recall of Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medic… by Bayer, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1673-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-03 |
| Published | 2014-06-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bayer |
| Distribution | US |
Product
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 outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
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.
Identifiers
| code_info | catalog number 3008895 : material numbers 3008236, 3009966, 3009917 with serial numbers: 1048 200619 200585 200656…catalog number 3008895 : material numbers 3008236, 3009966, 3009917 with serial numbers: 1048 200619 200585 200656 300010 100066 14498 100087 200305 200663 200248 200606 300047 1040 100182 100187 200442 200037 200716 200111 300051 1041 100428 100128 200479 200586 200648 200009 300045 100107 100037 100213 200665 200034 200722 200134 300027 100272 100457 100215 200601 200109 200298 200135 100220 100273 100482 100141 200615 200121 200558 200593 300036 100401 11210 100488 200117 200313 200618 200465 300033 100409 10328 100129 200540 200515 200187 1045 300034 100404 15187 100083 200401 200119 20398 200045 300042 100299 10407 100006 200115 1068 200051 14857 300026 100300 100233 100188 200432 200267 1073 200557 300049 100399 100266 100226 200497 200689 200022 200322 30020 100400 14076 100271 200200 200771 200089 200346 300013 100184 100265 100069 200012 200075 200090 200655 3000 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1673-2014%22
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