Events

Device Recall FASTx Sternal Intraosseous Device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pyng Medical 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
    59019
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2687-2011
  • 사례 시작날짜
    2010-11-05
  • 사례 출판 날짜
    2011-06-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-08-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100841
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • 원인
    Device failed to operate; the insertion of the infusion tube of the fastx sternal intraosseous device was not achieved in live subjects.
  • 조치
    Pyng Medical Corp. sent a "FSN/RECALL FOR FASTx STERNAL INTRAOSSEOUS DEVICE, P/N FASTx -H" letter dated November 5, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers are to cease distribution and use of all devices. All devices remaining in inventory should be quarantined. Customers are asked to complete the information at the bottom of the letter and return the product by FEDEx. Questions regarding this notice should contact the Director of Operations at 1-604-303-7964 ext. 211.

Device

Device Recall FASTx Sternal Intraosseous Device
  • 모델명 / 제조번호(시리얼번호)
    3 lot numbers: "20100609", "20100610", and 20100611". Format is "YYYYMMXX" where YYYY is the year of manufacture, MM is the month, and XX is a sequential number identifying different lots manufactured in the same month.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, England, Italy, Mexico, Poland, and Sweden.
  • 제품 설명
    The product is the "FASTx Sternal Intraosseous Device". || The expiration date for the recalled products is end of June, 2012. || The device is used to insert an infusion tube into the manubrium (upper portion of the sternum) of a patient. It is intended for intraosseous infusion as an alternative to intravenous access, to facilitate emergency resuscitation through the use of drugs and fluids. It is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.
  • Manufacturer
    Pyng Medical Corporation

Manufacturer

Pyng Medical Corporation
  • 제조사 주소
    Pyng Medical Corporation, 13511 Crestwood Pl Rm 7, Richmond Canada
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA