Events

Device Recall Engage TR Introducer, 6 F ACT (2.25 mm), 25 cm length, .035" 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 St. Jude Medical Cardiovascular Division 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
    56222
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2180-2010
  • 사례 시작날짜
    2010-06-28
  • 사례 출판 날짜
    2010-08-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93017
  • 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
    Introducer, Catheter - Product Code DYB
  • 원인
    Potential for a partial or complete separation of the shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. if either of these were to occur during use, it is likely that fluids would leak around the introducer hub and strain relief.
  • 조치
    Consignees were sent "Urgent Medical Device Recall Notice" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory. Sales Representatives were also sent a St. Jude Medical Memorandum "Field Action Notice" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks. A St. Jude Medical sales representative will be contacting for removal and replacement of the affected product. For additional information, please contact St. Jude Medical at 651-491-4470.

Device

Device Recall Engage TR Introducer, 6 F ACT (2.25 mm), 25 cm length, .035"
  • 모델명 / 제조번호(시리얼번호)
    Batch in US and OUS: 3107645
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including USA, Italy, Denmark, France, Switzerland, England, Finland, Austria, Spain and Estonia.
  • 제품 설명
    St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408513, 100017549.
  • Manufacturer
    St. Jude Medical Cardiovascular Division

Manufacturer

St. Jude Medical Cardiovascular Division
  • 제조사 주소
    St. Jude Medical Cardiovascular Division, 14901 Deveau Pl, Minnetonka MN 55345
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA