Class 1 Device Recall Colleague 3, 3 CX and 3 CXE Volumetric Infusion Pumps

• Date Initiated by Firm: June 20, 2007
• Date Posted: July 18, 2007
• Recall Status: Terminated on December 20, 2011
• Recall Number: Z-1091-2007
• Recall Event ID: 38219
• 510(K)Number: K063696
• Product Classification: Infusion Pump - Product Code FRN
• Product: Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8163, 2M9163
• Code Information: product codes 2M8153: serial numbers 10070004CT, 10070015CT, 10070024CT, 10070035CT, 10070054CT, 10070072CT, 10070079CT, 10070107CT, 10070119CT, 10070125CT, 10070150CT, 10070166CT, 10070175CT, 10070177CT, 10070182CT, 10070185CT, 10070253CT, 10070266CT, 10070272CT, 10080018CT, 10080053CT, 10080064CT, 10080072CT, 10080084CT, 10080147CT, 10080171CT, 10080181CT, 10080215CT, 10080221CT, 10080226CT, 10080302CT, 10080419CT, 10080424CT, 10080469CT, 10080483CT, 10080503CT, 10080510CT, 10080511CT, 10080524CT, 10080571CT, 10080590CT, 10080615CT, 10080631CT, 10080637CT, 10082059CT, 10082114CT, 10082179CT, 10082183CT, 10082218CT, 10082224CT, 10082411CT, 10090025CT, 10090099CT, 10090115CT, 10090166CT, 10090201CT, 10090205CT, 10090211CT, 10090228CT, 10090235CT, 10090243CT, 10090283CT, 10090371CT, 10090421CT, 10090452CT, 10090466CT, 10090472CT, 10090482CT, 10090491CT, 10090494CT, 10090496CT, 10090545CT, 10090557CT, 10090587CT, 10090596CT, 10090609CT, 10090636CT, 10090639CT, 10090644CT, 10090647CT, 10091362CT, 10100058CT, 10100095CT, 10100171CT, 10105027CT, 10105094CT, 10105144CT, 10105145CT, 10105163CT, 10105375CT, 10105411CT, 10105581CT, 10105643CT, 10105754CT, 10105890CT, 10106140CT, 10106167CT, 10106168CT, 10106206CT, 10106215CT, 10106217CT, 10106561CT, 10115040CT, 10115153CT, 10115363CT, 10115379CT, 10115408CT, 10115409CT, 10115468CT, 10115528CT, 10120023CT, 10120047CT, 10120115CT, 10120133CT, 10120143CT, 10120145CT, 10120153CT, 10120156CT, 10120164CT, 10120170CT, 10120172CT, 10120192CT, 10120205CT, 10120239CT, 10120248CT, 10120270CT, 10120272CT, 10120283CT, 10120284CT, 10120298CT, 10120300CT, 10120397CT, 11010218CT, 11010252CT, 11010287CT, 11010364CT, 11010372CT, 11010384CT, 11010389CT, 11010410CT, 11010419CT, 11010421CT, 11010437CT, 11010447CT, 11010449CT, 11010453CT, 11010455CT, 11010458CT, 11020042CT, 11020096CT, 11020150CT, 11020241CT, 11020421CT, 11020503CT, 11020504CT, 11020635CT, 11020646CT, 11020649CT, 11020816CT, 11021004CT, 11021011CT, 11021013CT, 11030457CT, 11040049CT, 11040199CT, 11040208CT, 11040233CT, 11040297CT, 11040373CT, 11040386CT, 11040442CT, 11040488CT, 11040510CT, 11040518CT, 11040585CT, 11040614CT, 11040646CT, 11040722CT, 11040771CT, 11040786CT, 11040840CT, 11040862CT, 11040885CT, 11040900CT, 11040930CT, 11040977CT, 11040987CT, 11041018CT, 11050013CT, 11050014CT, 11050021CT, 11050024CT, 11050034CT, 11050057CT, 11050059CT, 11050060CT, 11050061CT, 11050063CT, 11050066CT, 11050070CT, 11050084CT, 11050093CT, 11050096CT, 11050097CT, 11050114CT, 11050117CT, 11050122CT, 11050127CT, 11050129CT, 11050140CT, 11050164CT, 11050175CT, 11050233CT, 11050238CT, 11050255CT, 11050266CT, 11051040CT, 11051098CT, 11051113CT, 11051132CT, 11060065CT, 11060070CT, 11060084CT, 11060141CT, 11060184CT, 11060195CT, 11070046CT, 11070081CT, 11070186CT, 11070215CT, 11070227CT, 11070238CT, 11070295CT, 11070390CT, 11070392CT, 11070412CT, 11070426CT, 11070430CT, 11070502CT, 11070518CT, 11070543CT, 11070550CT, 11070643CT, 11080045CT, 11080081CT, 11080183CT, 11080395CT, 11080404CT, 11080415CT, 11080465CT, 11080483CT, 11080625CT, 11080635CT, 11080733CT, 11080740CT, 11080755CT, 11080767CT, 11080770CT, 11080821CT, 11080870CT, 11080988CT, 11080991CT, 11081014CT, 11081085CT, 11081093CT, 11081109CT, 11081117CT, 11081129CT, 11081130CT, 11081173CT, 11081185CT, 11081187CT, 11081201CT, 11081214CT, 11081224CT, 11090009CT, 11090015CT, 11090047CT, 11090049CT, 11090052CT, 11090064CT, 11090069CT, 11090078CT, 11090110CT, 11090111CT, 11090134CT, 11090136CT, 11090144CT, 11090163CT, 11090180CT, 11090186CT, 11090189CT, 11090202CT, 11090209CT, 11090211CT, 11090212CT, 11090232CT, 11090237CT, 11090523CT, 11090555CT, 11090731CT, 11090764CT, 11090777CT, 11090784CT, 11090788CT, 11090815CT, 11090853CT, 11090870CT, 11090871CT, 11090882CT, 11090921CT, 11090889CT, 11090938CT, 11090943CT, 11090947CT, 11090952CT, 11090967CT, 11090968CT, 11090990CT, 11090995CT, 11090996CT, 11091005CT, 11091020CT, 11091029CT, 11091030CT, 11100058CT, 11100064CT, 11100117CT, 11100178CT, 11100280CT, 11100439CT, 11100463CT, 11100549CT, 11100558CT, 11100590CT, 11100605CT, 11100612CT, 11100635CT, 11100680CT, 11100689CT, 11100703CT, 11100714CT, 11100724CT, 11100748CT, 11100750CT, 11100754CT, 11100782CT, 11100817CT, 11100961CT, 11100979CT, 11100982CT, 11100986CT, 11100991CT, 11100994CT, 11100997CT, 11101011CT, 11101052CT, 11101083CT, 11101090CT, 11101134CT, 11101154CT, 11101274CT, 11101283CT, 11101292CT, 11101303CT, 11101318CT, 11101331CT, 11101363CT, 11101463CT, 11101475CT, 11101485CT, 11101508CT, 11101532CT, 11101537CT, 11101630CT, 11101653CT, 11101657CT, 11110053CT, 11110093CT, 11110110CT, 11110118CT, 11110156CT, 11110163CT, 11110165CT, 11110233CT, 11110404CT, 11110482CT, 11110563CT, 11120003CT, 11120005CT, 11120006CT, 11120007CT, 12010117CT, 12010189CT, 12010214CT, 12010378CT, 12010385CT, 12010417CT, 12010500CT, 12010503CT, 12010547CT, 12020034CT, 12020071CT, 12020082CT, 12020094CT, 12020115CT, 12020122CT, 12020153CT, 12020157CT, 12020196CT, 12030002CT, 12030121CT, 12030150CT, 12030215CT, 12030393CT, 12030395CT, 12030457CT, 12030495CT, 12040104CT, 12040170CT, 12040192CT, 12050077CT, 12050080CT, 12050105CT, 12060004CT, 12060042CT, 12060086CT, 12060099CT, 12060122CT, 12060126CT, 12060162CT, 12060234CT, 12060237CT, 12070123CT, 12070198CT, 12070223CT, 12070258CT, 12070262CT, 12080054CT, 12080060CT, 12080075CT, 12080093CT, 12080096CT, 12080113CT, 12080123CT, 12080128CT, 12080135CT, 12080144CT, 12080176CT, 12080259CT, 12090042CT, 12090055CT, 12090101CT, 12090132CT, 12090159CT, 12090179CT, 12090198CT, 12090209CT, 12090227CT, 12090267CT, 12090284CT, 12090299CT, 12090304CT, 12090349CT, 12090352CT, 12090391CT, 12090519CT, 12100013CT, 12100031CT, 12100181CT, 12100189CT, 12100190CT, 12100203CT, 12100220CT, 12100244CT, 12100295CT, 12100307CT, 12100324CT, 12100337CT, 12100409CT, 12100414CT, 12100500CT, 12100509CT, 12110001CT, 12110037CT, 12110080CT, 12110087CT, 12110088CT, 12110121CT, 12110142CT, 12110201CT, 12110280CT, 12110369CT, 12120036CT, 12120039CT, 12120059CT, 12120185CT, 12120195CT, 12120214CT, 12120222CT, 12120229CT, 12120239CT, 12120249CT, 12120254CT, 12120264CT, 12120299CT, 13030048CT, 13030095CT, 13030116CT, 13030122CT, 13030131CT, 13030178CT, 13030194CT, 13030210CT, 13060018CT, 13060063CT, 13070032CT, 13070048CT, 13070120CT, 13070160CT, 13070185CT, 13110027CT, 13110051CT, 14020070CT, 14020170CT, 14020205CT, 14030005CT, 14030091CT, 14030116CT, 14030122CT, 14030135CT, 14040006CT, 14040009CT, 14040011CT, 14040013CT, 14040021CT, 14040022CT, 14040023CT, 14040048CT, 14060168CT, 14100037CT, 15040031CT, RA01562CT; Product code 2M8163: serial numbers 11040028TC, 11060001TC, 11060020TC, 11060038TC, 11060074TC, 11060076TC, 11060083TC, 11060085TC, 11060106TC, 11060144TC, 11060152TC, 11060166TC, 11060224TC, 11060242TC, 11110002TC, 11110010TC, 11110012TC, 11110013TC, 11110014TC, 11110020TC, 11110024TC, 11110026TC, 11110029TC, 11110031TC, 11110035TC, 11110038TC, 11110039TC, 11110041TC, 11110043TC, 11110045TC, 11110048TC, 11110049TC, 11110052TC, 11110056TC, 11110057TC, 11110058TC, 11110060TC, 11110064TC, 11110065TC, 11110068TC, 11110072TC, 11110075TC, 11110080TC, 11110081TC, 11110083TC, 11110085TC, 11110089TC, 11110090TC, 11110105TC, 11110109TC, 11110110TC, 11110113TC, 11110129TC, 11110132TC, 11110139TC, 11110140TC, 11110142TC, 11110143TC, 11110147TC, 11110148TC, 11110150TC, 11110152TC, 11110155TC, 11110157TC, 11110168TC, 11110173TC, 11110174TC, 11110180TC, 11110183TC, 11110184TC, 11110193TC, 11110198TC, 11110202TC, 11110203TC, 11110206TC, 11110210TC, 11110217TC, 11110221TC, 11110228TC, 11110239TC, 11110250TC, 11110263TC, 11110269TC, 11110272TC, 11110276TC, 11110280TC, 11110285TC, 11110287TC, 11110293TC, 11110337TC, 11110346TC, 11110350TC, 11110358TC, 11110365TC, 11110368TC, 11110378TC, 11110413TC, 11110493TC, 11110504TC, 11110515TC, 11110549TC, 11110553TC, 11110598TC, 11110612TC, 11110706TC, 11110722TC, 11110809TC, 11110828TC, 11110854TC, 11110880TC, 11120030TC, 11120045TC, 11120049TC, 11120054TC, 11120070TC, 11120106TC, 11120121TC, 11120176TC, 11120221TC, 11120248TC, 11120262TC, 11120355TC, 11120392TC, 11120431TC, 11120441TC, 11120454TC, 11120469TC, 11120475TC, 11120483TC, 11120498TC, 11120518TC, 11120530TC, 11120565TC, 11120566TC, 11120600TC, 11120612TC, 11120638TC, 11120674TC, 11120685TC, 12010080TC, 12010105TC, 12010126TC, 12010170TC, 12010189TC, 12010206TC, 12010241TC, 12010244TC, 12010285TC, 12010339TC, 12010344TC, 12010367TC, 12010381TC, 12010382TC, 12010384TC, 12010416TC, 12010424TC, 12010432TC, 12030032TC, 12030037TC, 12030089TC, 12030106TC, 12030148TC, 12030193TC, 12030199TC, 12030204TC, 12040007TC, 12040053TC, 12040064TC, 12040095TC, 12040153TC, 12040186TC, 12040213TC, 12040220TC, 12040349TC, 12040439TC, 12050034TC, 12050044TC, 12050075TC, 12050085TC, 12050094TC, 12050103TC, 12050164TC, 12050197TC, 12050201TC, 12050223TC, 12050237TC, 12050246TC, 12050306TC, 12050333TC, 12050351TC, 12050356TC, 12050365TC, 12050390TC, 12050393TC, 12050395TC, 12050409TC, 12050426TC, 12050451TC, 12050487TC, 12050492TC, 12050494TC, 12050613TC, 12050619TC, 12050636TC, 12050671TC, 12050699TC, 12050764TC, 12050773TC, 12050798TC, 12060037TC, 12060038TC, 12060052TC, 12060071TC, 12060081TC, 12060087TC, 12060103TC, 12060115TC, 12060116TC, 12060124TC, 12060126TC, 12060130TC, 12060154TC, 12060161TC, 12060175TC, 12060179TC, 12060186TC, 12060187TC, 12060192TC, 12060193TC, 12060194TC, 12060253TC, 12060262TC, 12060277TC, 12060294TC, 12060298TC, 12060299TC, 12060301TC, 12060315TC, 12060316TC, 12060323TC, 12060325TC, 12060330TC, 12060332TC, 12060335TC, 12060338TC, 12060340TC, 12060353TC, 12060375TC, 12060380TC, 12060393TC, 12060404TC, 12060409TC, 12060417TC, 12060431TC, 12060433TC, 12060436TC, 12060441TC, 12060451TC, 12060475TC, 12060489TC, 12060494TC, 12060496TC, 12060504TC, 12060511TC, 12060522TC, 12060523TC, 12060528TC, 12060529TC, 12060253TC, 12060262TC, 12060277TC, 12060294TC, 12060298TC, 12060299TC, 12060301TC, 12060315TC, 12060316TC, 12060323TC, 12060325TC, 12060330TC, 12060332TC, 12060335TC, 12060338TC, 12060340TC, 12060353TC, 12060375TC, 12060380TC, 12060393TC, 12060404TC, 12060409TC, 12060417TC, 12060431TC, 12060433TC, 12060436TC, 12060441TC, 12060451TC, 12060475TC, 12060489TC, 12060494TC, 12060496TC, 12060504TC, 12060511TC, 12060522TC, 12060523TC, 12060528TC, 12060529TC, 12060535TC, 12060549TC, 12060601TC, 12060627TC, 12060629TC, 12060641TC, 12060657TC, 12060664TC, 12060682TC, 12060691TC, 12060692TC, 12060702TC, 12060704TC, 12060711TC, 12060720TC, 12060745TC, 12070020TC, 12070023TC, 12070030TC, 12070036TC, 12070037TC, 12070046TC, 12070049TC, 12070055TC, 12070069TC, 12070073TC, 12070094TC, 12070096TC, 12070101TC, 12070102TC, 12070105TC, 12070106TC, 12070108TC, 12070112TC, 12070124TC, 12070135TC, 12070140TC, 12070152TC, 12070171TC, 12070176TC, 12070215TC, 12070228TC, 12070239TC, 12070353TC, 12070368TC, 12070454TC, 12070479TC, 12070493TC, 12070609TC, 12070628TC, 12070674TC, 12070707TC, 12070716TC, 12070740TC, 12070745TC, 12070759TC, 12070761TC, 12070773TC, 12070777TC, 12070783TC, 12070796TC, 12070797TC, 12080012TC, 12080027TC, 12080036TC, 12080040TC, 12080092TC, 12080116TC, 12080124TC, 12080179TC, 12080187TC, 12080199TC, 12080233TC, 12080306TC, 12080347TC, 12080400TC, 12080499TC, 12080521TC, 12080527TC, 12080530TC, 12080549TC, 12080564TC, 12080568TC,,12080572TC, 12080593TC, 12080609TC, 12080614TC, 12080618TC, 12080649TC, 12080677TC, 12080683TC, 12080702TC, 12080709TC, 12080839TC, 12080863TC, 12080867TC, 12080873TC, 12090043TC, 12090044TC, 12090101TC, 12090167TC, 12090217TC, 12090230TC, 12090249TC, 12090325TC, 12090426TC, 12090589TC, 12090593TC, 12090594TC, 12090606TC, 12090626TC, 12090636TC, 12090650TC, 12090660TC, 12090665TC, 12090735TC, 12090746TC, 12090753TC, 12090759TC, 12090794TC, 12090800TC, 12090803TC, 12100007TC, 12100008TC, 12100011TC, 12100016TC, 12100019TC, 12100021TC, 12100025TC, 12100027TC, 12100030TC, 12100035TC, 12100041TC, 12100050TC, 12100051TC, 12100058TC, 12100069TC, 12100074TC, 12100080TC, 12100082TC, 12100089TC, 12100090TC, 12100091TC, 12100106TC, 12100108TC, 12100110TC, 12100112TC, 12100113TC, 12100114TC, 12100120TC, 12100121TC, 12100125TC, 12100126TC, 12100130TC, 12100132TC, 12100142TC, 12100145TC, 12100155TC, 12100156TC, 12100161TC, 12100165TC, 12100166TC, 12100168TC, 12100169TC, 12100170TC, 12100173TC, 12100174TC, 12100181TC, 12100185TC, 12100190TC, 12100193TC, 12100194TC, 12100199TC, 12100217TC, 12100238TC, 12100242TC, 12100247TC, 12100248TC, 12100297TC, 12100298TC, 12100325TC, 12100338TC, 12100363TC, 12100365TC, 12100380TC, 12100384TC, 12100389TC, 12100396TC, 12100416TC, 12100418TC, 12100478TC, 12100482TC, 12100501TC, 12100505TC, 12100552TC, 12100558TC, 12100571TC, 12100588TC, 12100592TC, 12100606TC, 12100614TC, 12100617TC, 12100626TC, 12100652TC, 12100663TC, 12100676TC, 12100691TC, 12100696TC, 12100699TC, 12100724TC, 12100729TC, 12100730TC, 12100731TC, 12100736TC, 12100740TC, 12100914TC, 12100915TC, 12100922TC, 12100930TC, 12100948TC, 12100954TC, 12100955TC, 12100995TC, 12101014TC, 12101018TC, 12101051TC, 12110020TC, 12110047TC, 12110079TC, 12110110TC, 12110139TC, 12110172TC, 12110188TC, 12110197TC, 12110199TC, 12110303TC, 12110325TC, 12110339TC, 12110389TC, 12110398TC, 12110435TC, 12110453TC, 12110461TC, 12110504TC, 12110510TC, 12110519TC, 12110552TC, 12110556TC, 12110582TC, 12110586TC, 12110596TC, 12110607TC, 12110626TC, 12110652TC, 12110653TC, 12110677TC, 12110683TC, 12110725TC, 12120035TC, 12120057TC, 12120086TC, 12120095TC, 12120135TC, 12120153TC, 12120154TC, 12120161TC, 12120250TC, 12120257TC, 12120262TC, 12120433TC, 12120457TC, 12120498TC, 12120546TC, 12120560TC, 12120567TC, 12120588TC, 12120623TC, 12120624TC, 12120669TC, 12120684TC, 12120841TC, 12120851TC, 12120883TC, 12120920TC, 12120923TC, 12120958TC, 12120968TC, 12120977TC, 12121000TC, 12121135TC, 12121136TC, 12121155TC, 12121167TC, 12121221TC, 12121233TC, 13010023TC, 13010030TC, 13010062TC, 13010081TC, 13020009TC, 13020052TC, 13030089TC, 13030143TC, 13030154TC, 13030178TC, 13030193TC, 13030195TC, 13030202TC, 13030225TC, 13030358TC, 13030366TC, 13030372TC, 13040078TC, 13040093TC, 13040127TC, 13040153TC, 13040168TC, 13040174TC, 13040231TC, 13040351TC, 13040382TC, 13040538TC, 13040557TC, 13040575TC, 13040587TC, 13040638TC, 13040703TC, 13040737TC, 13050066TC, 13050101TC, 13050104TC, 13050119TC, 13050148TC, 13050178TC, 13050224TC, 13050228TC, 13050243TC, 13050269TC, 13050282TC, 13050284TC, 13050330TC, 13050349TC, 13050421TC, 13050491TC, 13050494TC, 13050508TC, 13050534TC, 13050536TC, 13050537TC, 13050541TC, 13050550TC, 13050578TC, 13050586TC, 13050600TC, 13050604TC, 13050613TC, 13050627TC, 13050680TC, 13050693TC, 13050702TC, 13050717TC, 13050869TC, 13050885TC, 13050917TC, 13050957TC, 13060028TC, 13060046TC, 13060052TC, 13060121TC, 13060169TC, 13060188TC, 13060189TC, 13060226TC, 13060253TC, 13060289TC, 13060318TC, 13060330TC, 13060367TC, 13060471TC, 13070035TC, 13070079TC, 13070105TC, 13070115TC, 13070144TC, 13070180TC, 13070214TC, 13070215TC, 13070216TC, 13070217TC, 13070235TC, 13070242TC, 13070246TC, 13070278TC, 13070283TC, 13070313TC, 13070353TC, 13070365TC, 13070407TC, 13070501TC, 13070531TC, 13070548TC, 13070587TC, 13070600TC, 13070637TC, 13070653TC, 13070704TC, 13070726TC, 13070731TC, 13070771TC, 13070811TC, 13070822TC, 13070881TC, 13070911TC, 13070912TC, 13070973TC, 13070974TC, 13070975TC, 13070977TC, 13080011TC, 13080019TC, 13080030TC, 13080045TC, 13080051TC, 13080061TC, 13080065TC, 13080066TC, 13080067TC, 13080070TC, 13080075TC, 13080078TC, 13080081TC, 13080082TC, 13080084TC, 13080086TC, 13080087TC, 13080090TC, 13080108TC, 13080113TC, 13080128TC, 13080134TC, 13080140TC, 13080151TC, 13080153TC, 13080159TC, 13080183TC, 13080235TC, 13080256TC, 13080266TC, 13080272TC, 13080273TC, 13080279TC, 13080307TC, 13080324TC, 13080340TC, 13080350TC, 13080352TC, 13080360TC, 13080549TC, 13080574TC, 13080576TC, 13080583TC, 13080618TC, 13080683TC, 13080691TC, 13080748TC, 13080760TC, 13080797TC, 13080816TC, 13080896TC, 13080926TC, 13080949TC, 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15070279TC, 15070282TC, 15070283TC, 15070284TC, 15070285TC, 15070290TC, 15070291TC, 15070294TC, 15070298TC, 15070300TC, 15070301TC, 15070303TC, 15070308TC, 15070313TC, 15070314TC, 15070319TC, 15070320TC, 15070321TC, 15070323TC, 15070324TC, 15070325TC, 15070327TC, 15070330TC, 15070331TC, 15070335TC, 15070336TC, 15070342TC, 15070348TC, 15070350TC, 15070351TC, 15070353TC, 15070354TC, 15070356TC, 15070358TC, 15070360TC, 15070363TC, 15070364TC, 15070366TC, 15070367TC, 15070369TC, 15070370TC, 15070372TC, 15070375TC, 15070379TC, 15070381TC, 15070384TC, 15070387TC, 15070389TC, 15070398TC, 15070400TC, 15070401TC, 15070402TC, 15070403TC, 15070406TC, 15070407TC, 15070412TC, 15070414TC, 15070415TC, 15070416TC, 15070418TC, 15070419TC, 15070421TC, 15070424TC, 15070425TC, 15070426TC, 15070427TC, 15070428TC, 15070430TC, 15070431TC, 15070432TC, 15070434TC, 15070436TC, 15070437TC, 15070439TC, 15070442TC, 15070443TC, 15070445TC, 15070449TC, 15070450TC, 15070452TC, 15070454TC, 15070456TC, 15070457TC, 15070458TC, 15070460TC, 15070462TC, 15070463TC, 15070465TC, 15070467TC, 15070469TC, 15070470TC, 15070471TC, 15070475TC, 15070476TC, 15070478TC, 15070479TC, 15070480TC, 15070482TC, 15070488TC, 15070493TC, 15070497TC, 15070498TC, 15070502TC, 15070505TC, 15070506TC, 15070511TC, 15070513TC, 15070781TC, 15070782TC, 15070783TC, 15070784TC, 15070785TC, 15070786TC, 15070787TC, 15070788TC, 15070789TC, 15070790TC, 15070791TC, 15070792TC, 15070793TC, 15070794TC, 15070795TC, 15070797TC, 15070799TC, 15070800TC, 15070801TC, 15070803TC, 15070804TC, 15070805TC, 15070806TC, 15070807TC, 15070808TC, 15070809TC, 15070810TC, 15070811TC, 15070812TC, 15070813TC, 15070814TC, 15070815TC, 15070816TC, 15070817TC, 15070818TC, 15070819TC, 15070820TC, 15070821TC, 15070822TC, 15070823TC, 15070824TC, 15070825TC, 15070826TC, 15070828TC, 15070829TC, 15070830TC, 15070831TC, 15070832TC, 15070833TC, 15070834TC, 15070835TC, 15070837TC, 15070838TC, 15070839TC, 15070840TC, 15070841TC, 15070842TC, 15070843TC, 15070844TC, 15070845TC, 15070846TC, 15070847TC, 15070848TC, 15070849TC, 15070850TC, 15070851TC, 15070852TC, 15070853TC, 15070854TC, 15070855TC, 15070856TC, 15070857TC, 15070858TC, 15070859TC, 15070860TC, 15070861TC, 15070862TC, 15070863TC, 15070864TC, 15070865TC, 15070868TC, 15070869TC, 15070870TC, 15070872TC, 15070873TC, 15070874TC, 15070875TC, 15070876TC, 15070878TC, 15070880TC, 15070881TC, 15070882TC, 15070884TC, 15070885TC, 15070886TC, 15070887TC, 15070888TC, 15070889TC, 15070890TC, 15070892TC, 15070893TC, 15070894TC, 15070895TC, 15070896TC, 15070898TC, 15070899TC, 15070900TC, 15070903TC, 15070904TC, 15070905TC, 15070906TC, 15070907TC, 15070908TC, 15070909TC, 15070910TC, 15070911TC, 15070912TC, 15070913TC, 15070914TC, 15070915TC, 15070916TC, 15070917TC, 15070918TC, 15070919TC, 15070920TC, 15070921TC, 15070922TC, 15070923TC, 15070924TC, 15070925TC, 15070926TC, 15070927TC, 15070928TC, 15070929TC, 15070930TC, 15070931TC, 15070932TC, 15070933TC, 15070935TC, 15070936TC, 15070937TC, 15070938TC, 15070939TC, 15070940TC, 15070941TC, 15070942TC, 15070943TC, 15070944TC, 15070945TC, 15070947TC, 15070948TC, 15070949TC, 15070950TC, 15070951TC, 15070952TC, 15070953TC, 15070954TC, 15070955TC, 15070956TC, 15070957TC, 15070958TC, 15070959TC, 15070960TC, 15070961TC, 15070963TC, 15070964TC, 15070965TC, 15070966TC, 15070967TC, 15070968TC, 15070969TC, 15070970TC, 15070971TC, 15070973TC, 15070974TC, 15070975TC, 15070976TC, 15070977TC, 15070978TC, 15070979TC, 15070980TC, 15070981TC, 15070984TC, 15070985TC, 15070986TC, 15070988TC, 15070991TC, 15070992TC, 15070993TC, 15070995TC, 15070996TC, 15070997TC, 15070999TC, 15071001TC, 15071002TC, 15071003TC, 15071004TC, 15071005TC, 15071006TC, 15071007TC, 15071008TC, 15071009TC, 15071010TC, 15071011TC, 15071012TC, 15071013TC, 15071014TC, 15071015TC, 15071016TC, 15071017TC, 15071018TC, 15071019TC, 15071020TC, 15071022TC, 15071024TC, 15071026TC, 15071027TC, 15071029TC, 15071030TC, 15071031TC, 15071085TC, 15071090TC, 15071092TC, 15071094TC, 15071096TC, 15071101TC, 15071107TC, 15071108TC, 15071124TC, 15071125TC, 15071130TC, 15071131TC, 15071134TC, 15071135TC, 15071139TC, 15071140TC, 15071144TC, 15071149TC, 15071153TC, 15071154TC, 15071156TC, 15071164TC, 15071172TC, 15071175TC, 15071180TC, 15071184TC, 15071188TC, 15071200TC, 15071203TC, 15071206TC, 15071207TC, 15071209TC, 15071215TC, 15071218TC, 15071221TC, 15071224TC, 15071225TC, 15071228TC, 15071231TC, 15071233TC, 15071236TC, 15071245TC, 15071247TC, 15071251TC, 15071252TC, 15071253TC, 15071256TC, 15071258TC, 15071259TC, 15071264TC, 15071268TC, 15071269TC, 15071271TC, 15071272TC, 15071273TC, 15071275TC, 15071278TC, 15071279TC, 15071284TC, 15071285TC, 15071290TC, 15071296TC, 15071299TC, 15071307TC, 15071308TC, 15071311TC, 15071314TC, 15071316TC, 15071318TC, 15071323TC, 15071324TC, 15071325TC, 15071326TC, 15071330TC, 15071331TC, 15071332TC, 15071337TC, 15071343TC, 15071353TC, 15071355TC, 15071356TC, 15071360TC, 15071361TC, 15071363TC, 15071370TC, 15071376TC, 15071378TC, 15071379TC, 15071381TC, 15071382TC, 15071384TC, 15071388TC, 15071390TC, 15071391TC, 15071395TC, 15071402TC, 15071405TC, 15071414TC, 15071415TC, 15071417TC, 15071424TC, 15071427TC, 15071428TC, 15071430TC, 15071432TC, 15071433TC, 15071437TC, 15071439TC, 15071443TC, 15071444TC, 15071448TC, 15071456TC, 15071458TC, 15071461TC, 15071465TC, 15071466TC, 15071469TC, 15071474TC, 15071477TC, 15071479TC, 15071486TC, 15071487TC, 15071490TC, 15071498TC, 15071500TC, 15071501TC, 15071503TC, 15071523TC, 15071524TC, 15071526TC, 15071532TC, 15071535TC, 15071537TC, 15071540TC, 15071544TC, 15071550TC, 15071560TC, 15071564TC, 15071570TC, 15071573TC, 15071577TC, 15071579TC, 15071580TC, 15071583TC, 15080001TC, 15080002TC, 15080003TC, 15080004TC, 15080005TC, 15080007TC, 15080008TC, 15080009TC, 15080010TC, 15080011TC, 15080012TC, 15080013TC, 15080016TC, 15080017TC, 15080019TC, 15080020TC, 15080021TC, 15080022TC, 15080023TC, 15080024TC, 15080025TC, 15080026TC, 15080027TC, 15080028TC, 15080030TC, 15080031TC, 15080032TC, 15080033TC, 15080034TC, 15080035TC, 15080036TC, 15080037TC, 15080040TC, 15080041TC, 15080042TC, 15080043TC, 15080044TC, 15080045TC, 15080046TC, 15080049TC, 15080051TC, 15080052TC, 15080053TC, 15080054TC, 15080055TC, 15080056TC, 15080057TC, 15080058TC, 15080060TC, 15080064TC, 15080065TC, 15080066TC, 15080067TC, 15080068TC, 15080069TC, 15080070TC, 15080072TC, 15080073TC, 15080074TC, 15080075TC, 15080076TC, 15080077TC, 15080079TC, 15080080TC, 15080081TC, 15080082TC, 15080083TC, 15080085TC, 15080086TC, 15080088TC, 15080090TC, 15080091TC, 15080092TC, 15080093TC, 15080094TC, 15080095TC, 15080096TC, 15080097TC, 15080099TC, 15080100TC, 15080101TC, 15080102TC, 15080103TC, 15080104TC, 15080105TC, 15080106TC, 15080107TC, 15080109TC, 15080110TC, 15080111TC, 15080112TC, 15080113TC, 15080114TC, 15080115TC, 15080116TC, 15080119TC, 15080120TC, 15080121TC, 15080122TC, 15080123TC, 15080124TC, 15080125TC, 15080126TC, 15080127TC, 15080128TC, 15080130TC, 15080131TC, 15080132TC, 15080133TC, 15080134TC, 15080135TC, 15080136TC, 15080138TC, 15080139TC, 15080141TC, 15080142TC, 15080143TC, 15080146TC, 15080147TC, 15080148TC, 15080149TC, 15080150TC, 15080151TC, 15080152TC, 15080153TC, 15080154TC, 15080155TC, 15080156TC, 15080157TC, 15080158TC, 15080159TC, 15080160TC, 15080161TC, 15080162TC, 15080164TC, 15080165TC, 15080166TC, 15080167TC, 15080168TC, 15080169TC, 15080170TC, 15080171TC, 15080172TC, 15080173TC, 15080174TC, 15080175TC, 15080176TC, 15080178TC, 15080179TC, 15080180TC, 15080181TC, 15080182TC, 15080183TC, 15080185TC, 15080186TC, 15080187TC, 15080189TC, 15080190TC, 15080192TC, 15080193TC, 15080195TC, 15080197TC, 15080199TC, 15080200TC, 15080202TC, 15080203TC, 15080204TC, 15080205TC, 15080206TC, 15080207TC, 15080209TC, 15080210TC, 15080212TC, 15080213TC, 15080214TC, 15080215TC, 15080216TC, 15080218TC, 15080219TC, 15080221TC, 15080222TC, 15080223TC, 15080225TC, 15080226TC, 15080227TC, 15080229TC, 15080230TC, 15080231TC, 15080232TC, 15080233TC, 15080235TC, 15080236TC, 15080238TC, 15080239TC, 15080240TC, 15080242TC, 15080243TC, 15080244TC, 15080246TC, 15080247TC, 15080248TC, 15080251TC, 15080252TC, 15080254TC, 15080255TC, 15080256TC, 15080258TC, 15080259TC, 15080261TC, 15080262TC, 15080263TC, 15080264TC, 15080265TC, 15080266TC, 15080268TC, 15080269TC, 15080270TC, 15080271TC, 15080272TC, 15080273TC, 15080274TC, 15080275TC, 15080277TC, 15080279TC, 15080280TC, 15080282TC, 15080283TC, 15080284TC, 15080285TC, 15080287TC, 15080289TC, 15080290TC, 15080291TC, 15080292TC, 15080293TC, 15080294TC, 15080295TC, 15080296TC, 15080298TC, 15080299TC, 15080300TC, 15080301TC, 15080302TC, 15080303TC, 15080304TC, 15080305TC, 15080307TC, 15080308TC, 15080310TC, 15080312TC, 15080313TC, 15080314TC, 15080315TC, 15080316TC, 15080317TC, 15080318TC, 15080319TC, 15080321TC, 15080322TC, 15080324TC, 15080325TC, 15080327TC, 15080329TC, 15080330TC, 15080331TC, 15080332TC, 15080334TC, 15080338TC, 15080339TC, 15080340TC, 15080341TC, 15080342TC, 15080343TC, 15080344TC, 15080345TC, 15080348TC, 15080350TC, 15080352TC, 15080353TC, 15080354TC, 15080355TC, 15080356TC, 15080358TC, 15080359TC, 15080361TC, 15080362TC, 15080363TC, 15080364TC, 15080365TC, 15080366TC, 15080367TC, 15080370TC, 15080371TC, 15080372TC, 15080373TC, 15080375TC, 15080376TC, 15080377TC, 15080379TC, 15080380TC, 15080381TC, 15080382TC, 15080383TC, 15080384TC, 15080385TC, 15080387TC, 15080388TC, 15080390TC, 15080391TC, 15080392TC, 15080393TC, 15080395TC, 15080397TC, 15080399TC, 15080400TC, 15080401TC, 15080402TC, 15080403TC, 15080404TC, 15080405TC, 15080406TC, 15080409TC, 15080410TC, 15080411TC, 15080412TC, 15080413TC, 15080414TC, 15080416TC, 15080417TC, 15080418TC, 15080420TC, 15080421TC, 15080422TC, 15080423TC, 15080424TC, 15080425TC, 15080426TC, 15080427TC, 15080429TC, 15080430TC, 15080431TC, 15080432TC, 15080433TC, 15080434TC, 15080435TC, 15080437TC, 15080439TC, 15080440TC, 15080441TC, 15080442TC, 15080443TC, 15080444TC, 15080445TC, 15080446TC, 15080447TC, 15080448TC, 15080449TC, 15080450TC, 15080452TC, 15080453TC, 15080454TC, 15080455TC, 15080456TC, 15080457TC, 15080458TC, 15080459TC, 15080464TC, 15080465TC, 15080467TC, 15080468TC, 15080469TC, 15080470TC, 15080471TC, 15080472TC, 15080474TC, 15080475TC, 15080476TC, 15080477TC, 15080478TC, 15080479TC, 15080482TC, 15080483TC, 15080484TC, 15080485TC, 15080486TC, 15080487TC, 15080488TC, 15080489TC, 15080490TC, 15080491TC, 15080492TC, 15080493TC, 15080494TC, 15080496TC, 15080497TC, 15080498TC, 15080499TC, 15080501TC, 15080502TC, 15080503TC, 15080505TC, 15080506TC, 15080602TC, 15080607TC ,15080616TC , 15080625TC, 15080626TC, 15080628TC, 15080637TC, 15080643TC, 15080644TC, 15080653TC, 15080657TC, 15080660TC, 15080663TC, 15080668TC, 15080671TC, 15080672TC, 15080674TC, 15080684TC, 15080686TC, 15080688TC, 15080690TC, 15080691TC, 15080702TC, 15080705TC, 15080707TC, 15080718TC, 15080722TC, 15080726TC, 15080735TC, 15080736TC, 15080737TC, 15080744TC, 15080753TC, 15080755TC, 15080756TC, 15080782TC, 15080797TC, 15080799TC, 15080821TC, 15080831TC, 15080834TC, 15080865TC, 15080884TC, 15080887TC, 15080889TC, 15080890TC, 15080894TC, 15080897TC, 15080905TC, 15080913TC, 15080919TC, 15080921TC, 15080932TC, 15080934TC, 15080937TC, 15080940TC, 15080942TC, 15080945TC, 15080949TC, 15080950TC, 15080958TC, 15080967TC, 15080972TC, 15080981TC, 15080982TC, 15080997TC, 15081010TC, 15081012TC, 15081015TC, 15081017TC, 15081022TC, 15081032TC, 15081036TC, 15081067TC, 15081082TC, 15081085TC, 15081087TC, 15081093TC, 15081101TC, 15081106TC, 15081120TC, 15081124TC, 15081155TC, 15081159TC, 15081160TC, 15081173TC, 15081188TC, 15081189TC, 15081211TC, 15081217TC, 15081220TC, 15081255TC, 15081263TC, 15081267TC, 15081281TC, 15081288TC, 15081293TC, 15081298TC, 15081302TC, 15081336TC, 15081400TC, 15081404TC, 15081407TC, 15081429TC, 15081434TC, 15081442TC, 15081479TC, 15081484TC, 15081493TC, 15081517TC, 15081522TC, 15081526TC, 15081542TC, 15081569TC, 15081578TC, 15081586TC, 15081595TC, 15081610TC, 15081611TC, 15081612TC, 15081627TC, 15090605TC, 15090612TC, 15090613TC, 15090615TC, 15090616TC, 15090623TC, 15090626TC, 15090628TC, 15090632TC, 15090636TC, 15090638TC, 15090646TC, 15090647TC, 15090650TC, 15090653TC, 15090655TC, 15090657TC, 15090659TC, 15090661TC, 15090664TC, 15090665TC, 15090667TC, 15090669TC, 15090672TC, 15090674TC, 15090676TC, 15090677TC, 15090678TC, 15090681TC, 15090691TC, 15090695TC, 15090696TC, 15090697TC, 15090698TC, 15090699TC, 15090701TC, 15090702TC, 15090705TC, 15090716TC, 15090717TC, 15090721TC, 15090723TC, 15090724TC, 15090727TC, 15090730TC, 15090731TC, 15090734TC, 15090738TC, 15090739TC, 15090741TC, 15090742TC, 15090744TC, 15090745TC, 15090746TC, 15090747TC, 15090751TC, 15090752TC, 15090754TC, 15090755TC, 15090756TC, 15090758TC, 15090759TC, 15090765TC, 15090766TC, 15090769TC, 15090772TC, 15100483TC, 15100492TC, 15100493TC, 15100496TC, 15100502TC, 15100505TC, 15100513TC, 15100519TC, 15100522TC, 15100536TC, 15100542TC, 15100546TC, 15100548TC, 15100549TC, 15100558TC, 15100559TC, 15100565TC, 15100566TC, 17040008TC, 17040013TC, 17040016TC, 17040019TC, 17040025TC, 17040043TC, 17040046TC, 17040047TC, 17040058TC, 17040063TC, 17040068TC, 17040087TC, 17040095TC, 17040151TC, 17040153TC, 17040157TC, 17040158TC, 17040181TC, 17050277TC, 17050312TC, 17050326TC, 17050382TC, 17050389TC, RA01554TC; Product code 2M9163: serial numbers 17010002TP, 17010003TP, 17010004TP, 17010005TP, 17010006TP, 17010007TP, 17010008TP, 17010011TP, 17010015TP, 17010016TP, 17010018TP, 17010019TP, 17010020TP, 17010021TP, 17010022TP, 17010023TP, 17010024TP, 17010025TP, 17010031TP, 17010032TP, 17010033TP, 17010034TP, 17010035TP, 17010036TP, 17010037TP, 17010038TP, 17010039TP, 17010040TP, 17010041TP, 17010042TP, 17010043TP, 17010044TP, 17010045TP, 17010046TP, 17010047TP, 17010048TP, 17010049TP, 17010050TP, 17010051TP, 17010052TP, 17010053TP, 17010054TP, 17010055TP, 17010061TP, 17010062TP, 17010063TP, 17010064TP, 17010065TP, 17010066TP, 17010067TP, 17010068TP, 17010069TP, 17010070TP, 17010071TP, 17010072TP, 17010073TP, 17010074TP, 17010075TP, 17010076TP, 17010077TP, 17010078TP, 17010079TP, 17010080TP, 17010081TP, 17010082TP, 17010083TP, 17010084TP, 17010085TP, 17040001TP, 17040002TP, 17040003TP, 17040004TP, 17040005TP, 17040006TP, 17040007TP, 17040008TP, 17040009TP, 17040010TP, 17040011TP, 17040012TP, 17040013TP, 17040014TP, 17040015TP, 17040016TP, 17040017TP, 17040018TP, 17040019TP, 17040020TP, 17040021TP, 17040022TP, 17040023TP, 17040024TP, 17040025TP, 17040026TP, 17040027TP, 17040028TP, 17040029TP, 17040030TP, 17040031TP, 17040032TP, 17040033TP, 17040034TP, 17040035TP, 17040036TP, 17040037TP, 17040038TP, 17040039TP, 17040040TP, 17040041TP, 17040042TP, 17040043TP, 17040044TP, 17040045TP, 17040046TP, 17040047TP, 17040048TP, 17040049TP, 17040051TP, 17040052TP, 17040053TP, 17040054TP, 17040055TP, 17040056TP, 17040057TP, 17040058TP, 17040059TP, 17040060TP, 17040061TP, 17040062TP, 17040064TP, 17040065TP, 17040066TP, 17040068TP, 17040069TP, 17040070TP, 17040071TP, 17040072TP, 17040073TP, 17040074TP, 17040075TP, 17040076TP, 17040077TP, 17040078TP, 17040079TP, 17040080TP, 17040081TP, 17040082TP, 17040083TP, 17040084TP, 17040085TP, 17040086TP, 17040087TP, 17040088TP, 17040089TP, 17040090TP, 17040091TP, 17040092TP, 17040093TP, 17040094TP, 17040095TP, 17040096TP, 17040097TP, 17040098TP, 17040099TP, 17040100TP, 17040101TP, 17040102TP, 17040103TP, 17040104TP, 17040106TP, 17040107TP, 17040108TP, 17040109TP, 17040110TP, 17040111TP, 17040112TP, 17040113TP, 17040114TP, 17040115TP, 17040116TP, 17040117TP, 17040118TP, 17040119TP, 17040120TP, 17040121TP, 17040122TP, 17040123TP, 17040124TP, 17040125TP, 17040126TP, 17040127TP, 17040128TP, 17040129TP, 17040130TP, 17040131TP, 17040132TP, 17040133TP, 17040134TP, 17040135TP, 17040136TP, 17040137TP, 17040138TP, 17040139TP, 17040140TP, 17040141TP, 17040142TP, 17040143TP, 17040144TP, 17040145TP, 17040146TP, 17040147TP, 17040148TP, 17040149TP, 17040150TP, 17040151TP, 17040152TP, 17040153TP, 17040154TP, 17040155TP, 17040156TP, 17040157TP, 17040158TP, 17040159TP, 17040160TP, 17040161TP, 17040162TP, 17040163TP, 17040164TP, 17040165TP, 17040166TP, 17040167TP, 17040168TP, 17040169TP, 17040170TP, 17040171TP, 17040172TP, 17040173TP, 17040174TP, 17040175TP, 17040176TP, 17040177TP, 17040178TP, 17040179TP, 17040180TP, 17040181TP, 17040217TP, 17040218TP, 17040219TP, 17040220TP, 17040221TP, 17040222TP, 17040223TP, 17040224TP, 17040225TP, 17040226TP, 17040227TP, 17040228TP, 17040229TP, 17040230TP, 17040231TP, 17040232TP, 17040233TP, 17040234TP, 17040235TP, 17040236TP, 17040237TP, 17040238TP, 17040239TP, 17040240TP, 17040241TP, 17040242TP, 17040243TP, 17040244TP, 17040245TP, 17040246TP, 17040247TP, 17040248TP, 17040249TP, 17040250TP, 17040251TP, 17040252TP, 17040253TP, 17040254TP, 17040255TP, 17040257TP, 17040258TP, 17040259TP, 17040260TP, 17040261TP, 17040262TP, 17040263TP, 17040264TP, 17040265TP, 17040266TP, 17040267TP, 17040268TP, 17040269TP, 17040270TP, 17040271TP, 17040272TP, 17040273TP, 17040274TP, 17040275TP, 17040276TP, 17040277TP, 17040278TP, 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• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; Rt. 120 & Wilson Rd; Round Lake IL 60073
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: A software anomaly is causing newly upgraded Colleague Triple Channel Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels simultaneously infusing fluids. In reported cases, the pump stopped infusing and both an audible and a visual alarm notification were activated.
• FDA Determined Cause: Software design
• Action: Baxter telephoned the direct accounts on 6/20-21/07, informing them that Baxter has received multiple reports of newly upgraded Colleague Triple Channel Infusion Pumps alarming, displaying an error code and stopping infusion. These reported events occurred during user programming with all three channels simultaneously infusing fluids. In all cases, the pump stopped the infusions and both an audible and visual alarm notification were activated. The accounts were requested to immediately remove the affected triple channel pumps, identified by two attached hangtags entitled "Battery" and "Power On", from service. The accounts were informed that their Baxter representative would be in contact with them to coordinate the replacement of the affected pumps with upgraded single channel pumps or non-upgraded triple channel pumps, if available. Any questions were directed to Baxter's Medication Delivery Services at 1-800-843-7867. Baxter sent follow-up Urgent Product Recall letters dated 6/22/07.
• Quantity in Commerce: 4,512 pumps
• Distribution: Worldwide, including USA, Canada, Australia, Belgium, New Zealand, South Africa, Thailand, and Singapore.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN and Original Applicant = BAXTERHEALTHCARE, INC.