Events

Device Recall Terumo Custom Cardiovascular Kits 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Cardiovascular Systems 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
    74856
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2706-2016
  • 사례 시작날짜
    2016-07-25
  • 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=148609
  • 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
    Cardiovascular procedure kit - Product Code OEZ
  • 원인
    Terumo custom cardiovascular procedure kits are labeled as xcoating surface coated tubing, but tubing is non-coated.
  • 조치
    Terumo Cardiovascular Systems issued the Safety Alert dated July 25, 2016 and advises the user that their kit may include uncoated tubing, and further advises the consignee to continue using their kits with consideration of anticoagulation protocols during a procedure. Each consignee is asked to complete a Customer Response Form, and to return the Customer Response Form to Terumo acknowledging their receipt of the form. Consignees can return their affected product for credit/replacement; however, return of the product from the field is a customer option and is not under recommendation from Terumo Cardiovascular Systems. For further questions, please call (800) 262-3304.

Device

Device Recall Terumo Custom Cardiovascular Kits
  • 모델명 / 제조번호(시리얼번호)
    US Lot Codes: UG06  UE18R  UF31  UF31A  UF31T    UG13  UG13A  UG20  UG20T  UG27  UG27T   OUS Lot Codes:  UG13  UG13T  UG20  UG20T
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Foreign: Canada, Latin America
  • 제품 설명
    Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: || This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a sterile, disposable kit, intended for one-time use for periods up to 6 hours, after which it must be discarded in a manner which is within applicable laws and practices. Terumo Cardiovascular System Cardiovascular Procedure Kits. Each kit is assigned a unique product code/catalog number that is specific to the consignee who has established specifications for the kit. || US Product Codes: || 72021 || 72358 || 71180-01 || 76021 || 76022 || 76023 || 76024 || 76025 || 71801-01 || 71801-01 || 71801-01 || 71801-01 || 71801-01 || 74163-03 || 71296-01 || 74460-01 || 74460-01 || 74460-01 || 73208-03 || 74382-01 || 74382-01 || 74382-01 || 74916 || 74916 || 74916 || 70089-07 || 74063-01 || 74063-01 || 74460-01 || 74460-01 || 74460-01 || 74460-01 || 75252-01 || 74951 || 75881 || 74271-01 || 71085-02 || 72742 || 75314 || 75368 || 75368 || 76095 || 76095 || 73339-01 || 73789 || 74417 || 72204 || 72965-03 || 73644 || 73645-01 || 73700 || 73861 || 73871 || 73901-03 || 75612 || 75617 || 75986 || 76095 || 73645-01 || 73645-01 || 70099-04 || 75544 || 75272 || 75674 || 75674 || 73180 || 73180 || 73180 || 75437 || 75674 || 75274 || 73811 || 73811 || 74915 || 71175-03 || 73738 || 76117 || 75129 || 75642 || 75642 || 72596 || 72596 || 72596 || 75179 || 74980-01 || 8340TXC-07 || 8340TXC-07 || 8340TXC-07 || 71875-01 || 74235-01 || 74476 || 75059 || 75547 || 75547 || 74235-01 || 8351TXC-01 || 73124 || 73281-01 || 73282-01 || 73874 || 74477 || 8340TXC-07 || 76069 || 76070 || 76071 || 76072 || 74737 || 73933 || 73933 || 73933 || 73933 || 73933 || 73933 || 71608-04 || 75413 || 74959 || 75472 || 75472 || 75449 || 75923 || 75923 || 73729-01 || 73730-01 || 74046-
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • 제조사 주소
    Terumo Cardiovascular Systems Corp, 28 Howe St, Ashland MA 01721-1305
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA