Device Recall Portex First Breath Adult Face Tent with Tubing 188cm 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smiths Medical 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
    57906
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2654-2011
  • 사례 시작날짜
    2011-02-11
  • 사례 출판 날짜
    2011-06-24
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2018-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Medication therapy tent, adult - Product Code BYG
  • 원인
    A sticky substance on the inside and/ or outside of the mask.
  • 조치
    Smiths Medical notified consignees by letter on 2/14/11 titled Urgent Medical Device Correction Notice via U.S. Mail (USA only) This Notice includes an Urgent Medical Device Correction Notice Confirmation Form that provides instructions to consignees to return unused affected product to Smiths Medical and to complete the effectivity tracking form. On 3/17/11 Smiths Medical issued an additional recall letter to extend the recall to 3 additional lots not included in the original recall letter dated 2/14/11. Also, the firm issued a recall letter on 3/17/11 to include the Value Pack (VP1302) General Anesthesia Kit to include 7 kit lots. Contact Recall Coordinator 1-800-348-6064 prompt 4, ext 2273

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  10-09
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Armenia, Brazil, Canada, France, Hungary, Italy, Jordan, Japan, Libya, Poland, Russian Federation, and Saudi Arabia.
  • 제품 설명
    First Breath ¿ Adult Face Tent with Tubing 188cm (5ft.) (Non-latex) || Reorder Number: 001492 || Face Tent Is a special type of aerosol mask used when the delivery of oxygen is not the primary objective. Normally this type of mask is used to deliver an aerosol mist to cool and moisturize the nasal passages or sinuses after surgery
  • Manufacturer

Manufacturer

  • 제조사 주소
    Smiths Medical, Hythe, Hythe, Kent United Kingdom
  • 제조사 모회사 (2017)
  • Source
    USFDA