Events

Recall of Belmont Rapid Infuser

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Belmont Instrument Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62703
  • Event Risk Class
    Class 2
  • Event Number
    Z-0058-2013
  • Event Date Posted
    2012-10-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111447
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion - Product Code FRN
  • Reason
    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.
  • 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.

Device

Belmont Rapid Infuser
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Belmont Rapid Infuser, a Fluid Management System, || Model FMS2000.
  • Manufacturer
    Belmont Instrument Corporation

Manufacturer

Belmont Instrument Corporation
  • Manufacturer Address
    Belmont Instrument Corporation, 780 Boston Rd, Billerica MA 01821-5925
  • Manufacturer Parent Company (2017)
    Belmont Instrument Corporation
  • Source
    USFDA