Devices

Device Recall Medtronic Venous Cannula

  • 모델명 / 제조번호(시리얼번호)
    Model #/ Lot #      C330201C C330201D C330201E C330206B C342603A C350103B  201778990 201333560 205081295 201308440 204054606 201551424 202046133 205309658 203601818 202303911 202640160 205320345 203954482 202632898 203901734 205382559 204022437 202749853 203988245 205405093 205295088 204702221 204083070 205430380 205341343  204140301 205382558  205009633          C350106A C390101D C390203D C390406C C390409B C390601C 203386584 201756864 201271206 201089120 201333454 201254615 204702226 201905232 201301780 201503223 201467644 201293772 204814118 202008866 201350933 201649278 202740140 201323302  201446358 201762036 202949628 201585473  201567009 202025197 203360831 201699263  201930998 202369699 203745171 201764741  202012666 202561642 204288932 201927157  202165777 203310174 204311077 201983847  202831965 203863206 204311078 202147109  203040326 203974731 204981269 202338794  203176693 204285949 204311100 202607179  203824089 204359270 205191686 203031085  203989352 204772228 204311101 203280877  204083184 204942619 204311102   204140178 205058667 205402352   204524639 205198592 205505532   204878946 205502765   204981273   205090466   205167834   205260796   205284044   205322751   205389438            C390601D C390601E C390702A C390802A C390903A C391001B 201978568 204506615 201514769 201254604 201412703 201424864 203458279 204524638 201669440 201581163 201716502 203721546 204774490 201893277 201777104 203958431 204918792 202102480 202045021 204030513 205135410 202276601 203217589 204186594 205204813 203293858 203435712 204314702 205314074 203722121 203647848 204444206 205327511 203844438 203814643  205397133 203955760 203909330  204133788 203988762  204334538 204080477  204399838 204136158  204437462 204236435  204567894 204319619  204828993 204404301  204952274 204480662  205127283 205050557  205199773 205114489  205284050 205225609  205322756            C391102F C391104B C391104D C391104F C391203A C391203B 201260397 202335015 202648288 203814113 201592267 202335015 201316863 202721406 203912313 201779099 202564471 201328866 202956306 203989351 202031340 202648288 201354079 203435354 204315229 202201301 202629850 201582137 204486509 202721406 201685303 204703505 202956306 201767640 204976133 203212352 201923860 205135962 203457797 202018139 205284041 203703579 202147111 205357458 203829112 202338090 205455476 203958091 202607450 204005429 202832635 204133662 202978994 204339276 203218293 204421636 203420717 204642948 203657578 204796134 203824092 204943321 203966968 205059363 204038746 205113433 204080534  204323903  204424421  204501914  204921866  205014886  205114486  205291411  205459133  205512599  203824093          C392502A C392503A C410201D C410407A C410407B C431601A 204821370 204821369 201249841 201428181 205113428 205357187 205217073 204916548 201278746 201436433 205287910   205217281 201334984 201715753 205397136   201454169 201892654 205470270   201585444 201971522 205507854   201685309 202496001   201767422 202604823   201936374 203142177   202212131 203434662   202596479 203451447   202657601 203800302   202753829 204070146   202942379 204288401   203218561 204399839  203531683 204437258  203784895 204548389  203863203 204695802  203977359 204921862  204039082   204129083   204179722   204368226   204452404   204563923   204942617   205050810   205122774   205244751   205307931   205354349  205407856  202212132         C490901B S342603B 201748829 204426525 202689619  203819553  205086432  205203567
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the Virgin Islands and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, and Yemen.
  • 제품 설명
    Custom Packs/ Kerkrade. || Contain Medtronic Venous Cannula, Sterile EO. || Model #'s || C330201C, C330201D, C330201E, C330206B, C342603A, C350106A, C390101D, C390203D, C390406C, C390409B, C390601C, C390601D, C390702A, C390802A, C390903A, C391001B, C391102F, C391104F, C391203A, C391203B, C392502A, C392503A, C410201D, C410407A, C410407B, C431601A, C391104B, C391104D, C390601E, C350103B, C490901B, S342603B. || These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Management
  • 1 Event

제조사

Medtronic Inc. Cardiac Rhythm Disease Management
  • 제조사 주소
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St. N.E., Saint Paul MN 55112
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA