Events

Device Recall Shiley FlexTra 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nellcor Puritan Bennett 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
    31273
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0721-05
  • 사례 시작날짜
    2004-12-09
  • 사례 출판 날짜
    2005-04-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-01-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37577
  • 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
    Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal - Product Code JDH
  • 원인
    Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury.
  • 조치
    On 12/3/04, the firm issued letters to all its international consignees, informing them of the affected product and providing instructions on the recall.

Device

Device Recall Shiley FlexTra
  • 모델명 / 제조번호(시리얼번호)
    All codes are affected.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    The firm has indicated that product was released for distribution to 7 consignees in US and to 17 foreign countries via international distribution centers. The firm has indicated that a very limited number of the product was distributed in the US to selected facilities that were participating in customer preference testing, after the device had received 510(k) clearance and all remaining stock was collected and returned to the company. Tyco Healthcare/Nellcor shipped Tyco Healthcare affiliate offices outside of the US. Foreign distribution include: Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Holland, Italy, Norway, Poland, Singapore, Spain, Sweden, Switzerland and United Kingdom.
  • 제품 설명
    Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, || Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed; || 358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 358100, Size 10, FlexTra Cuffed; 359060, Size 6, FlexTra Uncuffed; 359070, Size 7, FlexTra Uncuffed; 359080, Size 8, FlexTra Uncuffed; 359090, Size 9, FlexTra Uncuffed; 359100, Size 10, FlexTra Uncuffed, || Tyco Healthcare/Nellcor is currently responsible for Research and Development for this product. Tyco Healthcare/MMJ S.A. De C.V., Cuidad Juarez, Mexico manufactures the FlexTra Tracheostomy Tube. The product is sterilized at Sterigenics, located at Santa Teresa, New Mexico.
  • Manufacturer
    Nellcor Puritan Bennett

Manufacturer

Nellcor Puritan Bennett
  • 제조사 주소
    Nellcor Puritan Bennett, 4280 Hacienda Dr, Pleasanton CA 94588-2719
  • Source
    USFDA