Device Recall Colleague and Colleague 3 CX Triple Channel Infusion Pumps

  • Model / Serial
    product code 2M8153, serial numbers 8071160CT, 8071419CT, 8071460CT, 8071630CT, 8071676CT, 8110465CT, 8110774CT, 8120247CT, 9010300CT, 9040241CT, 9050062CT, 9050857CT, 9070981CT, 9080100CT, 9100108CT, 10010454CT, 10060596CT, 10082498CT, 10105657CT, 10115474CT, 11050804CT, 11070179CT, 11090085CT, 11090787CT, 11101453CT, 12040018CT, 12080251CT, 12090380CT, 13070011CT;  product code 2M8163, serial numbers 11040006TC, 11110369TC, 11110524TC, 11110903TC, 11120155TC, 11120367TC, 11120602TC, 12010132TC, 12010139TC, 12010212TC, 12040347TC, 12040406TC, 12050073TC, 12050471TC, 12060559TC, 12060592TC, 12070054TC, 12070095TC, 12080203TC, 12080537TC, 12080556TC, 12090356TC, 12090444TC, 12090324TC, 12090534TC, 12090807TC, 12090808TC, 12100610TC, 12100434TC, 12100589TC, 12110134TC, 12110279TC, 12120513TC, 12120517TC, 13020058TC, 13040146TC, 13040567TC, 13050246TC, 13050308TC, 13050876TC, 13050896TC, 13050975TC, 13060359TC, 13060455TC, 13070124TC, 13070173TC, 13070192TC, 13070224TC, 13070835TC, 13070868TC, 13080319TC, 13081000TC, 13091208TC, 13091388TC, 13100605TC, 13110651TC, 13120024TC, 14060090TC, 14060125TC, 14060486TC, 14070276TC, 14070282TC, 14070286TC, 14070288TC, 14070291TC, 14070328TC, 14070330TC, 14070334TC, 14070337TC, 14070344TC, 14080003TC, 14080037TC, 14080041TC, 14080046TC, 14080068TC, 14080096TC, 14080117TC, 14082180TC, 14110267TC, 14110418TC, 14110433TC, 14110446TC, 14110459TC, 14110499TC, 14110685TC, 14110865TC, 14120461TC, 15040254TC, 15040255TC, 15040404TC.  -------------------------------------RECALL EXTENSION---------------------  Product code 2M8153, serial numbers 10010231CT, 10010384CT, 10010801CT, 10010810CT, 10010903CT, 10010922CT, 10010955CT, 10010964CT, 10011197CT, 10020177CT, 10040377CT, 10040384CT, 10060361CT, 10060584CT, 10060596CT, 10061003CT, 10082294CT, 10082540CT, 10082636CT, 10091091CT, 10091169CT, 10091219CT, 10091253CT, 10091302CT, 10091366CT, 10105371CT, 10105429CT, 10105461CT, 10105624CT, 10105853CT, 10105882CT, 10105929CT, 10106318CT, 10115181CT, 10120009CT, 10120024CT, 11010069CT, 11010147CT, 11010214CT, 11010272CT, 11020649CT, 11040593CT, 11040745CT, 11040775CT, 11040804CT, 11050781CT, 11050788CT, 11050812CT, 11050814CT, 11050844CT, 11050876CT, 11050889CT, 11050903CT, 11050938CT, 11051097CT, 11051214CT, 11051216CT, 11070083CT, 11070156CT, 11070164CT, 11070255CT, 11080081CT, 11080281CT, 11080283CT, 11080289CT, 11080414CT, 11080650CT, 11081087CT, 11081110CT, 11081114CT, 11081210CT, 11081211CT, 11090085CT, 11090180CT, 11090249CT, 11090432CT, 11090558CT, 11090787CT, 11100085CT, 11100122CT, 11100338CT, 11100457CT, 11101619CT, 11101661CT, 11110050CT, 11110062CT, 11110117CT, 11110129CT, 11110198CT, 11110458CT, 11110572CT, 12020032CT, 12020044CT, 12030039CT, 12030124CT, 12040056CT, 12040201CT, 12050028CT, 12050109CT, 12060086CT, 12070127CT, 12070132CT, 12070173CT, 12070239CT, 12080251CT, 12090067CT, 12090077CT, 12090091CT, 12090297CT, 12090299CT, 12100087CT, 12100203CT, 12100386CT, 13030261CT, 13060014CT, 13070129CT, 13070149CT, 14030113CT, 8050111CT, 8060037CT, 8060271CT, 8071436CT, 8071447CT, 8071452CT, 8071562CT, 8071568CT, 8071669CT, 8080090CT, 8080117CT, 8080139CT, 8080152CT, 8080185CT, 8080197CT, 8080243CT, 8080256CT, 8080398CT, 8080416CT, 8080500CT, 8080913CT, 8081006CT, 8090016CT, 8090912CT, 8091931CT, 8100019CT, 8100298CT, 8101099CT, 8101129CT, 8101219CT, 8101234CT, 8101236CT, 8101239CT, 8101324CT, 8101361CT, 8111105CT, 8111160CT, 8111185CT, 8111206CT, 8111314CT, 8111580CT, 8120607CT, 8120769CT, 8120908CT, 8120942CT, 9010070CT, 9010073CT, 9010094CT, 9010122CT, 9010291CT, 9020129CT, 9020215CT, 9030537CT, 9030546CT, 9040099CT, 9040239CT, 9040306CT, 9050113CT, 9050263CT, 9050314CT, 9050741CT, 9050799CT, 9050818CT, 9050923CT, 9070307CT, 9070613CT, 9070867CT, 9071099CT, 9071115CT, 9080218CT, 9090371CT, 9090432CT, 9090452CT, 9090462CT, 9090497CT, 9090500CT, 9100054CT;  Product code 2M8153R, serial numbers 10040226CT, 10082561CT, 10082632CT, 11070101CT, 8050101CT, 8050116CT, 8091694CT, 8111220CT, 8121195CT, 9060368CT, 9090764CT, 9100163CT;   Product code 2M8153U, serial numbers 10082566CT, 8101339CT, 8111288CT, 9010265CT, 9040075CT;   Product code 2M8163, serial numbers 11060011TC, 11060086TC, 11110068TC, 11110093TC, 11110195TC, 11110337TC, 11110358TC, 11110388TC, 11110398TC, 11110413TC, 11110417TC, 11110465TC, 11110512TC, 11110743TC, 11110801TC, 11110802TC, 11120175TC, 11120372TC, 11120522TC, 11120535TC, 11120544TC, 11120613TC, 12010053TC, 12050471TC, 12060591TC, 12060598TC, 12060703TC, 12070011TC, 12070039TC, 12070099TC, 12070129TC, 12070240TC, 12070604TC, 12070658TC, 12070708TC, 12070716TC, 12070738TC, 12070759TC, 12080116TC, 12080218TC, 12080222TC, 12080574TC, 12080589TC, 12080637TC, 12080868TC, 12080881TC, 12090090TC, 12090163TC, 12090165TC, 12090197TC, 12090271TC, 12090444TC, 12090465TC, 12090468TC, 12090471TC, 12090473TC, 12090492TC, 12090505TC, 12090513TC, 12090526TC, 12090541TC, 12090555TC, 12090569TC, 12090600TC, 12090622TC, 12090700TC, 12090766TC, 12090785TC, 12100198TC, 12100217TC, 12100292TC, 12100359TC, 12100449TC, 12100572TC, 12100613TC, 12100643TC, 12100655TC, 12100700TC, 12100725TC, 12100750TC, 12100754TC, 12110032TC, 12110076TC, 12110080TC, 12110086TC, 12110139TC, 12110152TC, 12110254TC, 12110320TC, 12110412TC, 12110422TC, 12110526TC, 12110722TC, 12120063TC, 12120066TC, 12120075TC, 12120084TC, 12120086TC, 12120726TC, 12120886TC, 12120966TC, 12120968TC, 12120986TC, 12121009TC, 12121079TC, 12121093TC, 12121100TC, 13010019TC, 13010039TC, 13020015TC, 13030358TC, 13040231TC, 13050075TC, 13050086TC, 13050093TC, 13050102TC, 13050129TC, 13050147TC, 13050252TC, 13050306TC, 13050331TC, 13050350TC, 13050386TC, 13050395TC, 13050428TC, 13050482TC, 13050603TC, 13050637TC, 13050648TC, 13050699TC, 13050729TC, 13050763TC, 13050873TC, 13060058TC, 13060065TC, 13060127TC, 13060293TC, 13070235TC, 13070498TC, 13070502TC, 13070622TC, 13070723TC, 13070797TC, 13070810TC, 13070824TC, 13070830TC, 13070836TC, 13070847TC, 13080132TC, 13081104TC, 13081219TC, 13081453TC, 13081477TC, 13081481TC, 13081491TC, 13091265TC, 13091438TC, 13091449TC, 13091470TC, 13091496TC, 13091885TC, 13091887TC, 13091999TC, 13100176TC, 13100246TC, 13100257TC, 13100653TC, 13100673TC, 13100687TC, 13100937TC, 13110421TC, 13110549TC, 13110628TC, 13110651TC, 13110691TC, 13110696TC, 13110712TC, 13120019TC, 13120084TC, 13120187TC, 13120289TC, 13120293TC, 13120393TC, 13120592TC, 13120635TC, 13120648TC, 13120677TC, 13120684TC, 13120692TC, 13120697TC, 13120824TC, 13120834TC, 13120901TC, 13120903TC, 13120974TC, 13121328TC, 13121389TC, 13121460TC, 14020152TC, 14060256TC, 14061114TC, 14061126TC, 14061142TC, 14061159TC, 14061175TC, 14061200TC, 14061220TC, 14061240TC, 14070326TC, 14080164TC, 14080790TC, 14080908TC, 14080914TC, 14080917TC, 14080942TC, 14080972TC, 14081106TC, 14081116TC, 14081439TC, 14081652TC, 14082050TC, 14082125TC, 14082133TC, 14100267TC, 14100454TC, 14100500TC, 14100504TC, 14100574TC, 14100604TC, 14100913TC, 14101451TC, 14110086TC, 14110171TC, 14110401TC, 14110427TC, 14110884TC, 14110918TC, 14110919TC, 14110921TC, 14110946TC, 14111085TC, 14111162TC, 14111701TC, 14120067TC, 14120113TC, 14120175TC, 15010174TC, 15010516TC, 15010559TC, 15010587TC, 15010715TC, 15021084TC, 15030767TC, 15030786TC, 15040048TC, 15040066TC, 15040084TC, 15040257TC, 15040358TC, 15040395TC, 15040404TC;  Product code 2M8163R, serial numbers 12010417TC, 12040249TC, 12040442TC, 12060275TC, 12120594TC, 13010039TC, 13050854TC;  Product code 2M8163U, serial numbers 12060435TC, 12060558TC   SECOND RECALL EXTENSTION: ***Extension #2 ***** Product code 2M8153, serial numbers 8071214CT, 8071449CT, 8101307CT, 9020127CT, 9020128CT, 9060170CT, 9120142CT, 10040377CT, 10040384CT, 10040398CT, 10040399CT, 10040406CT, 10040410CT, 10040414CT, 10040417CT, 10040428CT, 10040437CT, 10040441CT, 10040547CT, 10040597CT, 10040599CT, 10040615CT, 10040647CT, 10040674CT, 10040683CT, 10070056CT, 10082367CT, 10082384CT, 10082386CT, 10082396CT, 10082413CT, 10082482CT, 10082493CT, 10082548CT, 10082578CT, 10082580CT, 10082586CT, 10082636CT, 11070830CT, 11080794CT, 11080840CT, 11080862CT, 11080894CT, 11080903CT, 11080907CT, 12070142CT, 12090146CT;   Product code 2M8153U, serial numbers 10040456CT, 10040475CT, 10040500CT, 10040530CT, 10040557CT, 10040623CT, 10040627CT;   Product code 2M8163, serial numbers 11060239TC, 11120337TC, 11120353TC, 11120368TC, 11120373TC, 11120378TC, 11120388TC, 11120399TC, 11120404TC, 11120411TC, 11120412TC, 11120464TC, 11120526TC, 11120545TC, 11120574TC, 11120583TC, 11120609TC, 12010347TC, 12010355TC, 12010356TC, 12010359TC, 12010364TC, 12010368TC, 12010372TC, 12010378TC, 12010385TC, 12010391TC, 12010406TC, 12010410TC, 12010411TC, 12010415TC, 12010418TC, 12010422TC, 12010430TC, 12010431TC, 12010434TC, 12010444TC, 12010447TC, 12010453TC, 12010454TC, 12040001TC, 12040020TC, 12040027TC, 12040048TC, 12040055TC, 12040058TC, 12040065TC, 12040069TC, 12040071TC, 12040081TC, 12040089TC, 12040115TC, 12040129TC, 12040134TC, 12040139TC, 12040195TC, 12040433TC, 13030176TC, 13030229TC, 13030288TC, 13070126TC, 13070128TC, 13070158TC, 13070161TC, 13070204TC, 13070212TC, 13070538TC, 13070708TC, 14100416TC, 14100462TC, 14100551TC, 14100622TC, 14100678TC, 14100684TC, 14100690TC, 14100694TC, 14100709TC, 14100720TC, 14100721TC, 14110002TC, 14110007TC, 14110008TC, 14110009TC, 14110010TC, 14110011TC, 14110014TC, 14110015TC, 14110017TC, 14110029TC, 14110031TC, 14110036TC, 14110039TC, 14110044TC, 14110046TC, 14110047TC, 14110050TC, 14110053TC, 14110061TC, 14110072TC, 14110080TC, 14110141TC, 14110212TC, 14110215TC, 15021076TC, 15021088TC, 15021128TC, 15021167TC, 15021175TC, 15021178TC, 15021183TC, 15021208TC, 15021297TC, 15021311TC, 15021312TC, 15021315TC, 15021329TC, 15021333TC, 15021363TC, 15021369TC, 15021374TC, 15021376TC, 15021379TC, 15021382TC, 15021387TC, 15021388TC, 15021389TC, 15021394TC, 15021395TC, 15021402TC, 15021413TC, 15021419TC, 15021421TC, 15021432TC, 15021437TC, 15021442TC, 15021443TC, 15021447TC, 15021450TC, 15021455TC, 15021456TC, 15021459TC, 15021468TC, 15021472TC, 15021475TC, 15021485TC, 15021492TC, 15021493TC, 15021496TC, 15021497TC, 15021507TC, 15021517TC, 15021522TC, 15021536TC, 15021552TC, 15021557TC
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide: Alaska, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wyoming
  • Product Description
    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 and 2M8163 (Colleague CX Triple)
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA