Device Recall Colleague and Colleague 3 CX Triple Channel Infusion Pumps

  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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
  • 제품 설명
    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

제조사

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