Events

Device Recall Fisher & Paykel CPAP Mask 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fisher & Paykel Healthcare 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
    36955
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0974-2007
  • 사례 시작날짜
    2006-11-24
  • 사례 출판 날짜
    2007-06-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49665
  • 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
    CPAP mask - Product Code BZD
  • 원인
    Plastic tabs incorporated into the connector components of these cpap masks may break off if they are not cleaned in accordance with the instructions for use. in the event of a tab breaking off, it may enter the cpap system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. masks manufactured since april 2006 do not feat.
  • 조치
    Fisher & Paykel Healthcare Inc. commenced sending out letters by mail to consignees the week commencing 4 December 2006 advising consignees to quarantine and destroy affected product. A faxback form was also be provided for consignees to advise Fisher & Paykel Healthcare of quarantined and destroyed stock. The firm will supply consignees with replacement product as determined from completed faxback information. The firm will collate responses from consignees and will follow up with a letter to consignees who do not respond within a month of initial mail-out. The firm will then make telephone contact with any consignees who do not respond within a month of the second mail-out. Fisher & Paykel Healthcare Inc. estimated the completion of this voluntary recall by April 2007.

Device

Device Recall Fisher & Paykel CPAP Mask
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers for Part Numbers: 400HC202 (lot #s: 040802 to 051222),400HC203 (lot #s: 040719 to 051103), 400HC209 (lot #s: 041108 to 050920), 400HC502 (lot #s: 040825 to 060201), 400HC503 (lot #s:040830 to 051028), 400HC505 (lot #s: 050223 to 050726), 400HCHC510 (lot #s: 051007 to 051028) , 900HC402 (lot #s: 010918 to 060203), 900HC405 (lot#s: 030924 to 030925), 900HC406 (lot #s: 031110 to 060403), 900HC412 (lot #s: 020108 to 060203), 900HC441 (lot #s: 031110 to 060424) & 900HC463 (lot #s: 020108 to 040604)
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    Fisher & Paykel Spares CPAP Mask and Connectors, Part Numbers: 400HC202 (Elbow non-diffuser holes),400HC203 (Elbow + vent NR valve), 400HC209 (Oracle 452 flexitube kit vent NR), 400HC502 (HC407 mask no headgear), 400HC503 (HC431 mask no headgear), 400HC505 (Infinity HC481 mask base), 400HCHC510 (HC406 mask no headgear) , 900HC402 (Aclaim mask no headgear), 900HC405 (HC405 sleep lab mask kit), 900HC406 (HC405 mask no headgear), 900HC412 (Aclaim flexitube kit), 900HC441 (Elbow diffuser and swivel) & 900HC463 (HC451 flexitube kit). CPAP masks.
  • Manufacturer
    Fisher & Paykel Healthcare Inc

Manufacturer

Fisher & Paykel Healthcare Inc
  • 제조사 주소
    Fisher & Paykel Healthcare Inc, 15365 Barranca Parkway, Irvine CA 92618
  • Source
    USFDA