Reported Nov 9, 2022 · Ongoing
CritiCool, thermoregulation device
Belmont Instrument Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Belmont Instrument Corporation · 780 Boston Rd · Billerica, MA · 01821-5925
Is this the product you have?
- CritiCool, thermoregulation device
- Lot codes and dates
- UDI-DI07290107581110
- Serial Numbers9.91016E+13 9.91042E+13 9.91047E+13 9.91082E+13 9.91082E+13
268 of 268 codes
99785809000119911069810004399110698100044996371580001299820774000039971040500004998229410000699642945000069963715800008996429450000799785809000089978580900009999918660001999110008800035991100088000369910932170002099109321700026991109929000209910066330001199100663300014991016375000059911069810004899662274000079966227400012998999020000899959153000079995915300014996622740000899662274000119969231000003996923100000499692310000059969570100004996957010001499695701000189910820890003099109321700010998999020001299110992900011997407240000599102316800013997408510001199953557000039910820890002399108208900025996622740007996957010001699104180900007991072915000139910729150001699838749000029910820890002299109321700004997847120001499100663300013991006633000239995355500001999535550000199953555000039995355500003
9.96941E+12108 of 108 codes
99110698100045991109929000189911099290001599544529000169961427900008996923100000199694148000049969414800005996941480000199772513000079977251300008997725130000699772513000059977251300004997725130000399642945000029966227400014996923100000699695702000109969570200014997984160001199784712000019978471200022998187600000799886336000099989990200009999201530000699102316800021991041809000019911069810002199939014000059979841600006997984160001799702599000019969570200008997104040000299710404000039973538500002997353850000399735385000079979841600008997847120002999818760000029981876000003998187600000499820774000029983349200009998334920001299833493000089983349300011998334930001299833493000149986341500004998387490001199863415000039986341500001999679160000299967916000059910066330002199100663300010
9.98634E+12242 of 242 codes
995222400002699754377000059982294100010998334920000599833492000069983349300013998334930001599863415000139986341500012998634150001499863415000159986341500016998999020000599918251000019991825100006999182510000899920153000049992015300011999390140000499953557000149995915300001999591530001199959153000059995915300008999959153000039910231680000299102316800014991023168000179910231680001999102316800020991023168000249910324500000299103245000027991032450000299910418090000399104180900005991041809000109910418090001599104183000031991041830000329910418300003399104183000034991047288000019910472880000299104728800003991047288000059910472880000799104728800004991047288000119910472880000699107291500023991072915000329910804500000299108045000010991080450000159910804500001699108045000023991093217000079910932170000999109321700023
336 of 336 codes
996107340001299104183000005991041830000069910418300000799104183000008997653550000999110008800038997025990000299702599000039970259900005997025990000699695702000039969414800010996957020000799710405000099971040500014997353860000199735386000059973538600012997353860001599735386000079973538600010997353860001199735386000139979841600001997984160000499798416000039982294100014998334930000299833493000079983874900006998387490000799838749000099993901400002999390140000699939014000079993901400008999469050000199946905000029994690500003999469050000499946905000059994690500006999469050000799946905000089994690500009999469050001099715540000029978580900001998187600000599822941000119982294100012991006633000079910066330000899104183000012991047288000329978471200026998634150001099662274000019969570100001
- Amount recalled
- 158 (US); 803 (OUS)
Where it was sold
- Nationwide
Why it was recalled
Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue.
This product could cause temporary or reversible health problems — stop using it.
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