Events

Device Recall Colleague and Colleague 3 CX Triple Channel Infusion Pumps 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Corp. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    38221
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1114-2007
  • 사례 시작날짜
    2007-06-21
  • 사례 출판 날짜
    2007-07-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-03-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53190
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Infusion Pumps - Product Code FRN
  • 원인
    Falsified repair/test and inspection records: pumps submitted for repair or service may not have been properly repaired or serviced before being returned to the customer.
  • 조치
    Baxter telephoned the direct accounts starting on 6/21/07, informing them that functional verification testing may not have been performed on their Flo-Gard and/or Colleague infusion pumps before they were returned to them. Since Baxter has no evidence that this quality control testing was conducted on these pumps, the pumps may not function as designed. The accounts were requested to locate the affected pumps and take them out of service as soon as possible, and send them back to Baxter for the required functional verification testing. *** Baxter expanded the recall and telephoned the direct accounts starting on 7/30/07, informing them that the electrical safety testing may not have been performed on their Colleague infusion pumps before they were returned to them. Since Baxter has no evidence that this quality control testing was conducted on these pumps, the pumps may not function as designed. The accounts were requested to locate the affected pumps and take them out of service as soon as possible, and send them back to Baxter for the required electrical safety and all functional verification testing. Follow-up recall letters were sent to the accounts on 8/7/07 reiterating the telephone conversations and providing a list affected pump serial numbers to be removed from service and returned to Baxter for testing. They were also requested to report any malfunction or adverse event related to the Colleague or Flo-Gard Infusion Pumps to Baxter Corporate Product Surveillance at 1-800-437-5176. ****Recall 2 Extension******* Baxter expanded the recall for a second time via letter on 8/20/07 and telephone calls starting on 8/21/07, informing the direct accounts that Baxter's investigation found documentation inconsistencies by three more of their service technicians, representing the possibility of incomplete testing and/or documentation by these technicians who serviced Colleague infusion pumps at the account's facility. Without complete and properly do

Device

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
    General Hospital and Personal Use Devices
  • 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
    Baxter Healthcare Corp.

Manufacturer

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