Events

VORTRAN Automatic Resuscitator, VARPlus 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Vortran Medical Technology 1, Inc 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
    77072
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2092-2017
  • 사례 시작날짜
    2017-04-20
  • 사례 출판 날짜
    2017-04-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-10-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154926
  • 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
    Ventilator, emergency, powered (resuscitator) - Product Code BTL
  • 원인
    Vortran received a customer complaint that the spin-nut-dss connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread direction.
  • 조치
    Medical Device Recall letters were sent on April 20, 2017. Letters explained the reason for recall and listed the specific lots sent to each distributor along with dates, PO numbers and quantity. Vortran Medical asks that each distributor provide a list of customers who received the affected product so that they can notify them directly of the recall.

Device

VORTRAN Automatic Resuscitator, VARPlus
  • 모델명 / 제조번호(시리얼번호)
    Model PCE 5012; Lot number/ expiry date: 1419 PCE , 2019-03-12; 1434 PCE, 2019-06-04.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA, MS, FL
  • 제품 설명
    VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; || Model PCE-5012; Qty: 10 each. || Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory || support.
  • Manufacturer
    Vortran Medical Technology 1, Inc

Manufacturer

Vortran Medical Technology 1, Inc
  • 제조사 주소
    Vortran Medical Technology 1, Inc, 21 Goldenland Court Ste 100, Sacramento CA 95834-2427
  • 제조사 모회사 (2017)
    Vortran Medical Technology 1 Inc
  • Source
    USFDA