Events

VCARE 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ventlab 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
    26369
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0982-03
  • 사례 시작날짜
    2003-04-15
  • 사례 출판 날짜
    2003-07-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2003-08-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27574
  • 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, Manual (Resuscitator) - Product Code BTM
  • 원인
    Printed bag with instructions to verify the pressure with a 'certified manometer' was omitted in some of the product.
  • 조치
    Consignee was notified by fax on 3/15/2003. All product on hand were returned to Ventlab.

Device

VCARE
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 3332838D, 333238D5; Product Codes: VN3100OCP, VN3100MC, VN3100OCP-B, VN3100MCP-2 and VN3100OCB
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was distributed to one consignee in CA. The cases were returned to the recalling firm.
  • 제품 설명
    V*CARE, Infant Resuscitator, with 40 cm H¿O Pressure Limiting System & Pressure Port Adapter, VN 3000 Series, Non-Sterile. The product included a clear plastic bag with white background which included Direction for Use statement #5. To remove vomitus: Disconnect resuscitator from patient. Tap the patient valve several times while squeezing the bag body. Retest the resuscitator for proper functioning. VentLab Corporation, 2934 Highway 601N, Mockville, NC 27028.
  • Manufacturer
    Ventlab Corporation

Manufacturer

Ventlab Corporation
  • 제조사 주소
    Ventlab Corporation, 2934 Hwy 601 North, Mocksville NC 27028
  • Source
    USFDA