Events

Device Recall Oridion 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Oridion Medical 1987 Ltd. 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
    61329
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1333-2012
  • 사례 시작날짜
    2012-02-16
  • 사례 출판 날짜
    2012-03-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-09-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107810
  • 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
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • 원인
    Co2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
  • 조치
    Oridion notified Hospitals, Clinics, EMS with an "Important Communication" letter to clinicians dated February 12, 2012. The letter was intended to make US clinicians aware of an important issue relating to certain Oridion CO2 sampling lines, which may not fully meet quality requirements. In a few cases, paper and plastic particulate may be present in the packaged units at levels that exceed the visual specification. Recommended actions were included in the letter. Questions were directed to 1(781)-972-1252.

Device

Device Recall Oridion
  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Oridion CO2 sampling lines and water traps under the label: || Omnistream CO2 Sampling Lines: || OmniLine O2 Adult Part No.007609; || OmniLine O2 Pediatric Part No 007610; || Smart OmniLine Plus O2 Adult Part No.010177; || Smart OmniLine Plus O2 Adult (package of 100 units) Part No.010213; || Smart OmniLine O2 Pediatric Part No. 007606; || ;Smart OmniBloc O2 Part No. 010946 || Smart OmniLine Plus part No. 010172 || Smart OmniLine Plus (package of 100 units) Part No 010212; || Smart OmniLine Guardian O2 Part No. 012531; || Smart OmniLine Guardian O2 Long Part No. 012532 || OmniVentLine Set Part No. 012495
  • Manufacturer
    Oridion Medical 1987 Ltd.

Manufacturer

Oridion Medical 1987 Ltd.
  • 제조사 주소
    Oridion Medical 1987 Ltd., 7 Hamarpe St., P.O. Box 45025, Har Hotzvim Industrial Park, Jerusalem Israel
  • 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