Events

Device Recall Renegade Fiber Braided Microcatheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific Corporation 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
    53048
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0358-2011
  • 사례 시작날짜
    2009-08-24
  • 사례 출판 날짜
    2010-11-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-02-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84540
  • 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, continuous flush - Product Code KRA
  • 원인
    Sterility loss-- the sterile barrier pouch seal (top seal) may be breached by the product, resulting in loss of sterility which may result in transmission of disease or infection.
  • 조치
    Boston Scientific issued an Urgent Medical Device Recall letter dated August 26, 2009 identifying the affected devices, the issue prompting the recall, and actions to be taken by customers. Customers were instructed to determine if they have affected product in their inventory, and if so, immediately quarantine and return to Boston Scientific. Customers can contact Boston Scientific at 510 624-1734.

Device

Device Recall Renegade Fiber Braided Microcatheter
  • 모델명 / 제조번호(시리얼번호)
    Lots:  11249879, 11542408, 11750295, 11966695, 12156146, 12228393, 12365497, 12491154,  11253574, 11546053, 11756331, 11988066, 12156147, 12228443, 12365604, 12509751,  11257185, 11552115, 11776786, 11996448, 12156183, 12228444, 12365605, 12509758,  11268801, 11554501, 11793108, 12001306, 12170507, 12248055, 12365613, 12509920,  11271408, 11559603, 11800162, 12001562, 12170508, 12248109, 12365614, 12527317,   11562655,  11274973, 11572313, 11806766, 12001567, 12170516, 12248121, 12385142, 12527760,  11296064, 11573180, 11819657, 12001568, 12175704, 12262088, 12385143, 12527763,  11301389, 11577242, 11825864, 12021328, 12175706, 12270709, 12385158, 12527769,  11303513, 11580376, 11836834, 12028753, 12175708, 12270714, 12385224, 12546795,   11840079,  11307943, 11586443, 11843094, 12039033, 12175710, 12270983, 12402095, 12546199,  11318319, 11587960, 11849818, 12049925, 12175711, 12279662, 12402111, 12546941,  11319596, 11602048, 11857667, 12061129, 12175713, 12292373, 12421265, 12546946,  11423369, 11623809, 11869009 12068930, 12175717, 12296121, 12421267, 12560791,   12073876,  11425310, 11627605, 11876193, 12089556, 12175719, 12296833, 12421271, 12560192  11425314, 11631734, 11880345, 12104631, 12175724, 12297455, 12421274, 12578834  11429065, 11638177, 11884227, 12104678, 12194075, 12311446, 12439946, 12578835  11429069, 11649446, 11891449, 12108064, 12194077, 12311459, 12439951, 12578864   12194829,  11432583, 11656601, 11891458, 12120518, 12194831, 12311520, 12439954, 12614498,  11432584, 11678955, 11895180, 12120528, 12214586, 12326062, 12439958, 12634309,  11441965, 11682874, 11895183, 12123141, 12214589, 12330440, 12458414, 12634310,  11444027, 11695922, 11925162, 12133525, 12214592, 12330441, 12458475, 12634315,   12330443,  11445708, 11703970, 11927490, 12142142, 12214602, 12330465, 12458416, 12659579,  11461698, 11706368, 11933896, 12142150, 12214604, 12330476, 12458543, 12660000,  11469070, 11710717, 11941913, 12148683, 12214616, 12330511, 12458548,  11481564, 11714291, 11948975, 12148684, 12228116, 12348609, 12466721,  11534917, 11721375, 11959863, 12148687, 12228366, 12365495, 12466123,
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution Worldwide, including throughout the US.
  • 제품 설명
    Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; || Model Numbers: 18257, 18259; Product is distributed by || Boston Scientific Corporation, Natick, MA; || Product is manufactured by Boston Scientific Corporation, Cork, Ireland
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA