Belmont Rapid Infuser, a Fluid Management System
Medical device recall Z-0058-2013. Published in FDA’s Enforcement Report on Oct 24, 2012.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 24, 2012. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 2,913 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
2,913 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 2012012793 2012012808 2012012809 2012022821 2012022822 2012022855 2012032880 2012032881 2012032883 2012032885 2012032886 2012032887 2012032888 2012032891 2012032904 2012032906 2012032907 2012032908 2012032910 2012042942…
Every code shown here, 1,994 characters
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…
FDA’s list runs to 10,236 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 25, 2012.
- FDA classified it on Oct 12, 2012.
- FDA’s Enforcement Report published it on Oct 24, 2012.
- FDA terminated it on Feb 28, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Belmont Instrument Corporation, of Billerica, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: N/A.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 10,236 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.