FDAFDA · Food and drugs·Recall number Z-0058-2013
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
Published October 24, 2012 · Recall initiated: September 25, 2012
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
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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Belmont Instrument Corporation
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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