FDAFDA · Food and drugs·Recall number Z-1673-2014
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.
Published June 11, 2014 · Recall initiated: April 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bayer Corp
- Distributor
- Worldwide Distribution - USA (nationwide) including the countries of Australia, Brazil, Belgium, Canada, Germany, Singapore, South Africa, Poland, Mexico and UAE.
- Lot
- 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 300012 100185 1033 1047 200706 200076 200091 200509 300000 100405 100316 100098 200707 1047 200344 1006 200004 100173 100356 100051 200493 200031 200337 200175 300001 100174 10810 100148 200419 200512 200644 200103 300002 100259 100144 100297 200597 200430 200579 200436 300003 100283 100105 100449 100122 200348 200580 200104 300028 100375 14163 100452 200393 200276 200463 200105 300055 1000 11159 100454 200392 200205 200079 200204 300032 100517 100027 100458 200674 200469 200328 200443 300031 100518 100279 100072 200193 200268 200040 200444 300044 100521 100139 100084 200324 200000 200030 200225 300015 100212 100175 11132 200289 200627 200395 200421 1021 100284 14246 100304 200415 200583 200388 200396 300037 100036 100443 100257 200416 200087 200682 200047 300025 100545 100492 100447 200448 200136 200164 1020 300016 100433 100497 100529 200482 200137 200778 1012 300017 100434 100170 100487 200483 200270 200568 200124 300019 1019 100019 100537 200574 200581 200185 1008 300006 100296 14464 100515 200587 200641 200043 1064 300029 100135 10387 10213 200598 200213 200160 200049 300062 1038 14846 11179 200614 200186 200161 200450 300043 100354 100342 11310 200636 200157 200546 200113 300018 100408 100193 15065 200635 200233 200547 14877 300007 1031 100224 100210 200640 200700 200749 200237 300011 100199 100417 100243 200680 200514 14832 200142 300030 100473 100335 10509 200055 200352 14844 200252 14737 1027 100294 100336 200056 200318 200577 200671 300005 100438 100232 100484 200057 200221 200422 200397 300038 100439 100361 1030 200058 200149 200159 200709 300040 100033 100150 100161 200059 200211 1004 200710 300039 1002 100151 10354 200060 200414 200429 200166 300021 100197 100116 100359 200065 200708 200112 200165 300048 100198 100115 100372 200066 20020 200329 200084 300050 100260 100117 14709 200067 200020 200471 200220 300053 100510 100049 100057 200068 200254 200687 200378 300054 100511 100025 100054 200069 200223 200685 200561 300009 100512 100125 100501 100520 200150 1046 1016 300022 1011 100202 100496 200788 200226 1024 200464 100061 100203 100327 200351 200445 200338 200070 1017 100664 100029 200426 200418 200152 1023 100261 100665 100112 200477 200545 200138 200764 1001 100666 100113 200486 200144 200391 200294 100229 100667 11256 200011 200612 200454 200048 1037 100669 100114 200658 200478 200269 200455 1023 100468 11281 200326 200293 200386 200354 100096 200183 100411 200339 200460 200052 200170 100386 10320 100240 200340 200073 200244 200642 100134 100074 100008 200366 200074 200044 200053 100398 100132 100429 200694 200519 200470 200552 100060 100532 100093 200695
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.