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U.S. Department of Health and Human Services

Class 2 Device Recall Medrad

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 Class 2 Recall
Medrad
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Date Posted May 30, 2014
Recall Status1 Open
Recall Number Z-1673-2014
Recall Event ID 68293
Premarket Notification
510(K) Number
K073051 
Product Classification Pump, Infusion - Product Code FRN
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.
Code Information 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 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200550 200528 100274 100176 15290 20598 200624 200275 200639 100244 100298 200699 300021 1054 200616 200582 100494 100464 100475 200353 200096 200146 200732 100440 100542 100206 200046 200097 200621 200145 10089 100016 100011 200120 10783 200367 200440 10091 100456 100317 200130 200108 200516 200319 100100 100041 100320 200357 200625 200327 200320 100156 100204 100522 200129 200564 200676 200181 100442 100258 100000 200679 10471 200525 200182 100026 11382 100018 200629 200530 200198 200693 100225 10660 100149 200072 200098 200675 200667 100275 14417 10997 200122 200435 200099 200126 100228 100290 14255 200522 200114 200717 200500 100524 100208 100160 200191 200333 200032 200365 100310 14385 1046 200376 200711 200273 200021 100426 100189 100288 200511 200712 200274 200360 100252 100480 100209 200513 200214 100293 1059 100420 100177 200063 200517 200228 200282 200362 100421 100104 100133 200518 200229 200039 200670 100328 100251 11170 200521 10328 200078 200246 100247 100146 11254 200131 200132 200194 200358 100038 1034 14117 200720 200316 200083 200317 100234 10371 14588 200377 200085 200672 10380 1010 100350 15386 200381 200431 1022 1074 100246 100360 15408 200456 1063 200207 200302 100425 1008 100364 200774 200110 1051 200303 100062 100183 100368 200775 200638 200331 200433 100196 100500 100369 200315 200262 200295 200255 100323 200336 100370 200492 200405 14935 200256 100489 100190 100366 200347 200596 200529 200155 100423 100307 100371 200278 200260 200265 100034 100392 100461 200199 200240 200264 1035 14072 14725 1026 200116 200026 100333 100168 100289 200195 200219 200481 1021 100483 100295 200438 200232 200772 1004 100186 200019 200541 200321 200643 1015 100270 100531 200633 200447 1076 100324 100126 10579 1041 200143 200496 100158 10342 100162 1075 200176 200372 100256 10317 100355 200556 200024 20016 100379 100138 14602 200537 20024 200345 100377 100140 14814 200535 200266 200683 100381 100772 100101 200148 200480 1077 100382 100453 100180 200503 1005 200565 100383 100448 100050 200609 1052 200008 100445 100450 100219 200272 200332 200524 100446 100451 100305 200523 1069 200139 100014 14903 1044 200167 200382 200409 100099 100380 11356 200188 200140 200578 100309 100067 100249 200189 200201 200662 100348 100441 100120 200190 200605 200399 100236 100040 100241 1033 200562 200222 100493 10674 100068 200095 200567 200508 100507 100363 100075 200548 200569 200086 1024 100569 100519 200575 200271 200446 100030 1057 100301 200673 200854 200501 100039 100227 100119 200686 200704 200458 100109 100314 100302 200227 200466 200459 1018 100315 100002 1014 200001 1067 1022 100172 100076 200077 200560 1055 100403 100465 100077 200407 200652 200003 100418 100466 100078 200035 1042 200684 100455 100469 100339 200404 200123 200599 15159 100470 100340 200283 200081 200602 100103 100153 100123 200284 200341 200208 100052 100154 200765 200311 200726 200400 100053 200297 100181 200312 200791 200153 100055 100431 10011 200798 200411 200238 100056 100432 100216 200799 200080 200705 100238 100143 200174 200290 200406 200323 14897 100070 100001 200592 200309 200715 100478 100459 100005 200286 200474 200364 100536 100223 15194 200287 200554 200133 100064 100393 100444 200192 1017 200288 1012 100278 100476 200308 1001 200356 1026 1045 100142 200330 200507 200462 1030-1 100017 100009 200118 200196 200538 100322 100422 100544 200499 200457 200082 100390 100292 14414 200504 200242 200343 100394 100102 100373 200505 1019 200532 100085 100022 1056 200506 200151 200389 100407 100023 14471 1065 200660 1072 100059 100015 1016 200617 200637 200147 100157 100071 100073 200106 200534 1039 100082 100530 200156 200203 200236 200197 100094 100044 100248 1029 200029 200038 100262 10594 15097 200335 200544 200375 100263 14650 100127 200033 200216 200158 100264 15236 14380 200093 200263 200005 100088 200042 100534 200604 200027 200427 100334 1028 1066 200476 200475 200355 1007 1009 100106 200212 200387 1015 15739 10567 100028 200154 200004 200125 100179 100220 100167 200600 200412 200572 100242 14381 200669 200417 200549 100269 100003 200594 200235 200028 100430 100607 200015 200243 200062 100525 100191 200384 200010 1038 200425 100325 200403 200608 200363 100329 100124 200202 200584 200653 100145 100217
Recalling Firm/
Manufacturer
Bayer Corp
100 Global View Dr
Warrendale, Pennsylvania 15086-7601
For Additional Information Contact Customer Support
724-940-6910
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: 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. When you are ready to return your Continuum(s), please refer to: ® Enclosure 2: Disassembly Instructions. ® Enclosure 3: Continuum Return Form. We sincerely regret the inconvenience and impact of the recalls and subsequent removal of Continuum from the market. Should you have questions regarding the pro-rated refund program, please call 877-229-3767.
Quantity in Commerce 1347
Distribution Worldwide Distribution - USA (nationwide) including the countries of Australia, Brazil, Belgium, Canada, Germany, Singapore, South Africa, Poland, Mexico and UAE.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = MEDRAD, INC.
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