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U.S. Department of Health and Human Services

Class 2 Device Recall Belmont Rapid Infuser

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 Class 2 Recall
Belmont Rapid Infuser
see related information
Date Posted October 12, 2012
Recall Status1 Terminated on February 28, 2014
Recall Number Z-0058-2013
Recall Event ID 62703
Premarket Notification
510(K) Numbers
K091855  K972284 
Product Classification Pump, Infusion - Product Code FRN
Product Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
Code Information Serial Numbers: 2012012793 2012012808 2012012809 2012022821 2012022822 2012022855 2012032880 2012032881 2012032883 2012032885 2012032886 2012032887 2012032888 2012032891 2012032904 2012032906 2012032907 2012032908 2012032910 2012042942 2012042944 2012052946 2012052948 2012052958 M030139 "1003 Q050656 Q050657" "2012012782 2012012783" "2012012784 2012012785" "2012012794 2012012795 2012012801 2012012802 2012012803 2012012805 2012022826" "2012012810 U082129" "2012022823 2012022824" "2012022827 2012022828" "2012022829 2012022830 2012022831 2012022832 2012022833 2012022834 2012022835" "2012022847 2012022848" "2012022849 2012022850 2012022851" "2012022852 2012022853" "2012032878 2012032879" "2012032881 2012032882 U011950 T121937" "2012032889 S121587" "2012032894 V092579" "2012032895 2012032902" "2012032903 U032005" "2012032908 2012032909 2012032911 2012042933" "2012052952 2012052954" J010005 J050006 J050008 J050009 "J050010 J060012 K110075 M010129 I120001 N030242 P010456" "J060011 L080103 L110115 L110116 L110117" J060013 "J060013 M090183" "J060014 J080017" "J060015 K070065 N080286 N090294 T111921 T111922" "J060016 J080018 S021405 U092151" J080019 "J120032 Q040631" J120033 "J120038 J120039 U031995 U032000" "K020045 K050053 K050055 K050056 K050060 K050061 K050062 N110310 O070386 O070385" K020047 K020048 K020049 "K030050 L100105 L100107 L100108" K050058 "K070067 K070069 N060278" "K110074 J050007" L030086 "L040087 L040092 P050500 K030052 R071010 S021358 T061693" L040088 "L040089 L040090 " "L040091 M070179" "L050094 O070389 R091082" "L050095 M070173 " L080100 L100113 "M010128 M020133 P110573" "M020136 S041422" M030141 M030142 "M030146 M030147" M030148 "M030149 S051444 U011943 U011944" "M050164 M080181 P050495" "M050165 M050166" "M060168 O110437" "M060169 M060170 V072487" "M070171 M070172 R081041 U112182" "M070174 O010334 T121936" M070175 M070176 J110028 M090185 S061493 S061495 S081525 S091536 M110186 M120190 N040261 N040262 N040263 N040264 N060275 N040265 N050266 N050267 N120327 N120328 N060279 N060277 N060280 T031649 N080283 N100304 T061691 N090289 O080410 O090415 O090416 M010121 P050501 P050502 Q120789 N090290 O070380 N090292 N090293 N090295 N090297 N090299 N090298 K020046 N090300 N090296 N090301 O070381 N100303 Q040636 Q040637 N100306 N100307 R020837 T011614 U082125 N110309 N110312 O010330 O010331 O010332 Q040632 Q040633 Q040634 S021377 S021380 O010333 O090420 P100557 O010338 O010339 O020341 O010340 O020354 O020349 O020348 O020347 O020344 Q060679 O020355 O020356 O020359 Q120790 Q120791 O030360 O030366U O030367U P030472 U072109 O030369 P080540 R081027 R111172 O060375 O070376 O070382 U032016 V062428 O070384 V042334 O070387 P100556 Q120802 S061504 O070388 O070391 O070390 S021391 O070393 O070392 O070394 O080401 O080403 O080404 O080405 O080402 O080406 O080407 M030150 O010337 O080408 S051444 S051448 S121586 U092143 S101556 O080409 O090421 S011269 M020131 M050167 P110572 P030470 P050503 O100428 O110430 O110431 O110436 P030467 V012251 V012252 O110439 O120440 O120441 O120442 P010452 P010453 P010454 P010455 P010458 M020138 P020459 Q050651 Q120793 P030468 P030469 P030471 P030473 V102641 P050498 P050499 P050505 P050509 T111913 P060517 P080531 S101552 V102662 P080541 P080543 P100548 P100550 P100551 S051463 P100552 P120583 P120584 P100558 Q120781 Q120782 P100559 P110561 P110571 T031650 U092155 P120582 Q050638 Q090741 Q050639 Q050640 Q050650 R101152 S101568 Q050654 Q050659 V112667 Q050655 Q050658 O030362 O030365 N050268 Q060664 U072113 U072114 U072115 U082121 U082122 U082123 U082124 Q060665 S061494 S011281 Q070681 Q070682 M020132 M020135 M020137 K110076 K110079 K110080 K110081 K110082 P050496 L100110 L100111 L100112 L100114 L110118 L120119 Q070688 U021986 Q070689 Q070690 Q070691 J120034 J120036 Q090729 S121595 Q090730 Q090731 Q090732 S011254 S011265 Q090734 Q090733 Q090736 Q090735 Q090737 Q090739 Q090738 Q100742 Q100743 Q090740 Q100744 U011945 U011946 U011947 Q100745 Q110762 R081031 Q110763 Q110765 Q110766 Q110769 T061690 Q110771 Q110778 Q120786 S021357 Q120794 Q120795 Q120796 Q120800 R010808 R010810 R020834 R020835 R020836 R040941 R040942 R040943 R040944 T041657 R040945 R040946 R040947 R040948 R040949 R040950 R050951 R050953 T061691 R060974 R060975 R060976 R060977 U021992 R060980 R060982 R060983 R091070 R111187 T091823 R071008 T011616 T011617 R071009 R081028 R081058 R091073 R081059 R091067 T071755 R091068 R091071 R101153 R091069 R091072 T061725 R091075 R091079 S061491 S061499 R101146 R101148 R101147 R101154 R101150 R101151 R111162 S021352 S021381 S021382 R111163 R111170 V092602 V092605 V092606 R111164 R111171 R111173 R111174 R111175 R111165 R121224 R121226 R121227 R121228 S011275 S011277 U092140 U092142 R121229 R121231 R121230 S011264 S011273 S011279 R121233 R121234 R121236 R121239 R121241 V122774 R121243 S011251 S011252 S011253 S011255 S011256 O080406 S011259 S011310 S011314 S011262 S011270 S011272 S011284 S011286 R091074 N050269 N050270 N080287 N090288 S011274 S011278 S011282 S011283 S011285 S061501 S011287 S011289 S011309 V092614 S011290 Q110770 S011298 V052400 V092595 S011311 S011288 S021417 S011312 S011313 S011315 S021353 S021359 S021355 S021356 S021368 S021372 S021373 S021374 S021375 S021392 S021393 S021394 S021397 Q110772 Q110777 R071006 R101149 R121242 S021396 S021399 S021408 S021409 S041421 R030885 R040911 R040912 R040913 R040914 R040915 R040940 S021410 S041430 S041431 S021411 S021412 S021413 S021414 S021415 U021987 S041423 S101554 S111571 V072478 S041424 S051440 M120192 J120040 J080023 L050096 T031655 T041661 T061686 T061687 T061688 T061689 S041425 V102663 S041427 T121940 U082135 S051462 S051465 S051470 S051473 S061487 S061481 S061482 S061485 S041426 S051456 S051464 S051466 S051469 S051472 S051467 S061488 V052408 V012244 V012248 S111591 S121593 P060515 P060516 S011276 S061483 T081808 S061492 S061506 S091532 S061509 T091829 T091830 S081520 S081521 S081523 S081524 R091076U R091077U Q110767U S081531 S091533 S091539 S091551 S101553 S101555 S111569 S111570 S111572 S111573 S111574 T071750 S111575 S111576 S111582 S111592 S121584 S121596 S121585 T011615 T011618 T011619 T011620 S121590 T011621 T011622 T021627 T021628 T021629 T021633 T041658 U021988 T031642 T031643 T031646 T031644 T031645 T031648 2012022854 T031649 T041656 T041659 T041660 V042326 T041668 T041670 T061721 T061722 T061723 T061724 T061726 T061727 T061728 T071746 T071747 T071748 T071749 T071751 T011623 T011624 T011625 T011626 S061489 S061486 2012012806 2012032876 2012032877 T071753 T071754 T081795 T081796, T081797 T081798, T081800 T081799, T081801 T081802, T081803 T081804, T081805" T081807 T091822 T091825 T091826 T091827 T091831 T091852 T091854 T101888 T111893 T111896 T110920 T111889 T111890 T111891 T111892 T111895 T111894 T111898 T111903 T081791 T081792 T081793 T081794 T111897 T111904 T111905 T111909 T111910 T111911 T111912 T111914 T111916 T111918 T111923 T111924 T111925 T121929 T121930 L050097 L080099 M020134 Q050648 Q050649 J080026 T121932 T121933 T121934 S021403 S021384 S021385 S021386 S021387 S021388 S021389 S021390 S021395 Q120801 T121935 S021376 S021378 S021383 T121938 T121939 U011948 U011949 U011952 U021984 U021985 U021989 U021990 U021991 U021993 U031994 U032001 U032002 U032003 U032004 U032006 U032007 U032008 U032009 U032015 U032017 U032018 U032019 U032020 U032021 U032022 U032024 U032025 U072089 U072090 U072091 U072093 U032023B U042040, U052056 U112184, V062426 V072490, V022258 Q080723, R081065 U052048 U052049 U052052 U052058 U052059 U052060 U052062 U052068 V092553 U052069 V122724 U052070 U062081 U072094 U072095 V052407 V112701 U072096 U072097 U072106 U072107 U072110 U072111 U072112 U082126 U082127 U082136 V072477 U092144 M020130 M120195 P100553 U092146, N100302 O060374, O070377 P120576, N100302 O060374, O070377 P120576, U032012 U092148 U092150 U102173 U102174 U102175 U102176 U102177 U112190 U112191 U112192 U112194 U092152 U092153 U092156 U082128 S111583 T091828 U102160 P050504 P010457 O090424 U102161 Q070629 U102162 U102163 U102164 U102165 U102166 U102167 U102168 U102169 U102170 U102171 U102172 U102178 U112180 U112181 U122210 U122211 U122212 U122213 U122214 U122215 U122216 U122217 U122218 U122219 V012230 V012231 V012232 V012233 V012234 V012235 V012236 V012237 V012238 V012239 V012241 V012245 T071741 R111183 R121221 S061476 V012250 V012253 T091824 V012254 V022270 V022271 V022272 V022273 V022274 V022275 V022276 V022277 V022278 V022279 V022281 V02225 V022256 V022257 V022259 V022260 V022261" V022262 "V022280 U092159" V022282 "V022284 U112188" "V022285 V022288 V022289" "V022287 R081029 R121225 R121232 S011258 S011260 S011271" "V032291 V032292 S121594 T091832" "V032293 U092149" V032294 V032296 "V032297 V032298" "V032299 T071752" V032303 V032304 V032312 V032313 V042325 "V042328 P120580 P120581" "V042330 V072464 K020042 U052061 O070395 O070399" V042331 "V042332 V082492 V082494 V082495 V082496 V082498 V082499" "V042333 V032290 U052051" "V042349 V082491" "V042350 V042351 V042352 V122722 V122735 V032295" V042355 V042357 V052370 "V052371 R111176 R111186" V052375 V052376 "V052379 V052380 U092158 U112193" V052381 "V052385 V052388" V052390 "V052391 V052392" V052393 V052399 "V052401 U052050" "V052402 P080542 P080544 P080545 P100554 Q120787 S061503" "V052403 V092611" "V052404 V092598 V092599" V062427 "V072471 2012032909" "V072474 V072475 V072476" V072479 V072486 "V082493 V082497 V082500 V082521 V082522" "V092554 V092558" V092555 V092557 V092559 V092560 V092576 V092577 V092578 V092580 V092587 "V092589 V092590 V092591 Q040635 Q110768" "V092592 V092596 V092597 T031647 V082523 V092551 V092552" V092593 V092600 V092601 "V092603 V092609 V092610" V092607 V092608 V092612 V092613 V092615 "V102616 V102617 V102618" "V102619 S061498 Q060666 Q060678" "V102620 V122717" V102621 "V102622 U072088" "V102634 V102635" "V102636 V102637 V102638" V102639 V102640 V102644 "V102651 V102665" "V102655 R081030" "V102660 P120579 U052055" "V112668 V112670 V122716 V112666" "V112669 2012012807" V112670 V112671 "V112679 V112680" V112691 V112693 V112694 "V112695 V112702" V112704 "V112705 P050497 U102179 V022286" "V112706 V102625 V102633" V112707 "V112708 V122746 V122747" "V122718 V122720" V122721 "V122725 V122726 V122727" "V122731 U092157 V072472 V072473" V122734 "V122748 L100106 P080539" V122749 V122750 "V122750 V122775" V122771 V122772 V122773
Recalling Firm/
Manufacturer
Belmont Instrument Corporation
780 Boston Rd
Billerica, Massachusetts 01821-5925
For Additional Information Contact Uri Labadini, BS MT (ASCP), BSEE
978-663-0212 Ext. 128
Manufacturer Reason
for Recall
Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Power Entry Module causing an electrical flash at the power entry area.
FDA Determined
Cause 2
DESIGN: Device Design
Action Belmont Instrument initiated recall on 9/25/12. A "Field Correction" notice was provided that described the product issue and recommended actions. US-based sales representatives visited all facilities to provide the modified power cord/shield. For units sold outside the United States, the modified power cords were sent to distributors who would ensure the new power cords were provided to all facilities within their accounts.
Quantity in Commerce 2,913 units
Distribution Worldwide Distribution including Nationwide (USA) and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, England, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Jordan, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Peru, Puerto Rico, S. Korea, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, UK, United Arab Emirates, and Vietnam.
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 = BELMONT INSTRUMENT CORP.
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