Events

Device Recall Tubing Pack 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Perfusion Systems 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
    78977
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0535-2018
  • 사례 시작날짜
    2018-01-03
  • 사례 출판 날짜
    2018-01-30
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160995
  • 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
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • 원인
    Medtronic custom perfusion tubing packs contain terumo ops valves that were recalled due to a lack of flow through the valve.
  • 조치
    In response to an Urgent Safety Alert issued by Terumo Cardiovascular Systems (CVS) Medtronic initiated their safety alert verbally to their direct consignees on 10/23/2017, providing them with a copy of the Terumo Safety Alert dated 06/27/2017. The firm followed this action with a letter on 1/3/18 in which they stated that the action by Terumo CVS was changed to a recall, and , in response, Medtronic was following up as a recall and requested the products be returned.

Device

Device Recall Tubing Pack
  • 모델명 / 제조번호(시리얼번호)
    a) REF 2815R1, UPN/GTIN: 20885074191038, Lot/Serial Numbers: 210937492, 213151103, 213671744  b) REF 2D25R6, UPN/GTIN: 00613994268174, Lot/Serial Numbers: 209533592, 209759280, 209948919, 210174899, 210377603,  210478517, 210591995, 210767149, 211011818, 211210404,  211243436, 211542842, 211761616  c) REF 9M68R, UPN/GTIN: 20643169876648, Lot/Serial Numbers: 212067087, 212796361  d) REF BB4B15R13, UPN/GTIN: 00643169845121, Lot/Serial Numbers: 211804184, 212073924, 212266962, 212268301, 212385983, 212552883,  212796215, 213248430, 213583108  e) REF BB4B15R14, UPN/GTIN: 00763000025878, Lot/Serial Numbers: 213801240, 213868837  f) REF BB9L72R, UPN/GTIN: 00643169845077, Lot/Serial Numbers: 211715103  g) REF BB9L72R1, UPN/GTIN: 00643169872127, Lot/Serial Numbers:  212020797, 212174623, 212193001, 212301586, 212355584, 212428238,  212626142, 212884370, 213001157, 213248459, 213631247, 213672934,  213802501, 214072742, 214093025  h) REF CB1Z87R11, UPN/GTIN: 00643169741591, Lot/Serial Numbers: 211755326  i) REF CB4L56R24, UPN/GTIN: 00643169735989, Lot/Serial Numbers: 211654744, 211654745, 211800954  j) REF CB4L56R26, UPN/GTIN: 00643169906181, Lot/Serial Numbers: 212294432, 212404544, 212447345, 212489670, 213251146, 213251166,  213358174, 213573495, 213623995, 214053395  k) REF CB5S68R3, UPN/GTIN: 20613994490760, Lot/Serial Numbers: 210937507  l) REF CB7X82R4, UPN/GTIN: 00643169471986, Lot/Serial Numbers: 211050766, 211320749  m) REF CB7X82R5, UPN/GTIN: 00643169789517, Lot/Serial Numbers:  211423503, 211443209, 211443210, 211885323, 211991293, 212154744,  212235237, 212274655, 212428312, 212473311, 212671632, 212962650,  213126447, 213292357, 213377926, 213445426, 213494394, 213494396,  213672914, 213906498, 214043035, 214093030  n) REF HY6Y19R5, UPN/GTIN: 00643169510432, Lot/Serial Numbers: 210802114, 210945613, 211114272, 211210180, 211327621, 211654742,  211846417, 212235012, 212545229, 212835348  o) REF HY8M65R2, UPN/GTIN: 00643169661295, Lot/Serial Numbers: 210952226, 211335076, 211558225, 211722651, 212028419, 212222066,  212355669, 213001001, 213719738  p) REF TL8W39R6, UPN/GTIN: 00643169715097, Lot/Serial Numbers: 210731697, 210838201, 210937704
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    DE, IA, CA and Japan
  • 제품 설명
    Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
  • Manufacturer
    Medtronic Perfusion Systems

Manufacturer

Medtronic Perfusion Systems
  • 제조사 주소
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • 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