Events

Device Recall Cannulaide 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beevers Manufacturing & Supply, 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
    69627
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0483-2015
  • 사례 시작날짜
    2008-05-13
  • 사례 출판 날짜
    2014-12-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-11-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131194
  • 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, non-continuous (respirator) - Product Code BZD
  • 원인
    Cannulaide recalled may 2008 due to improper seal of the pouch. the improper seal of the cannulaide's package could potentially affect the device shelf life.
  • 조치
    Beevers Manufacturing & Supply, Inc. (BMS) did contact the customers via letter and phone call in May 2008. Customers that didn't reply were further contacted via email on June 2008. Salter Labs provided BMS' recall report to FDA in October 2014. Salter Labs was unable to locate a recall letter issued by BMS to the affected customers. For further questions please call (503) 472-9055

Device

Device Recall Cannulaide
  • 모델명 / 제조번호(시리얼번호)
    CA 101: Lot 54219; CA 102: Lot 52834; CA 103: Lot 53813;
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution including the states of LA, GA, OR, MA, NJ, FL and CA., and the countries of Canada, France, Japan, Netherlands and United Kingdom.
  • 제품 설명
    Cannulaide, Model 101, 102, 103. Respirator. || The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. || The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose. || It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on infants ranging from less than 700 grams to greater than 3000 grams. It is a non-sterile, single patient use, disposable device.
  • Manufacturer
    Beevers Manufacturing & Supply, Inc.

Manufacturer

Beevers Manufacturing & Supply, Inc.