Events

Device Recall Howell D.A.S.H. Extraction Balloon 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Wilson-Cook Medical 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
    27445
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0068-04
  • 사례 시작날짜
    2002-08-28
  • 사례 출판 날짜
    2003-10-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2003-11-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29889
  • 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
    Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection - Product Code GCA
  • 원인
    The product was labeled with a 5 year expiration date instead of a 1 year expiration date.
  • 조치
    Field Representatives were notified via Fax or E-mail in August/September, 2002. After being notified about the recall, field representatives were responsible for notifying facilities about the market withdrawal and for furnishing instructions for returning products for credit.

Device

Device Recall Howell D.A.S.H. Extraction Balloon
  • 모델명 / 제조번호(시리얼번호)
    Lots 1602780, 160281, 1602782, 1602784, 1602785, 1602786, 1602788, 1602789, 1602790, 1602791, 1602792, 1602793, 1602794, 1602795, 1602796, 1602797, 1602798, 1602799, 1602800, 1602801, 1602802, 1607143, 1607144, 1610890, 1611901, 1613669, 1613670, 1614712, 1615429, 1615745, 1617031, 1617649, 1618498, 1620684, 1620928., 1621381, 1621496, 1621691, 1621692, 1622879, 16254321, 1626364, 1626669, 1627928, 1628134, 1629489, 1630384, 1630385, 1633042, 1633043, 1620783, 1623781, 1624348, 1625245, 1627107, 1629245, 1630813, 1634319, 1633787, 1634878, and 1635692.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide; Argentina, Australia, Barbados, Bolivia, WI, Brazil, Canada, Costa Rica, Central Hong Kong, Colombia, Ecuador, El Salvador, England, Egypt, Guatemala, India, Indonesia, Ireland, Israel, Japan, Korea, Malaysia, Mexico, New Zealand, Pakistan, Philippines, Peoples Republic of China, Poland, Republic of Panama, Romania, Saudi Arabia, Singapore, Sri Lanka, Syria, Taiwan, Thailand, United Arab Emirates, Venezuela, Uruguay.
  • 제품 설명
    Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only, Wilson-Cook Medical, 4900 Bethania Station Road, Winston-Salem, NC 27105.
  • Manufacturer
    Wilson-Cook Medical Inc

Manufacturer

Wilson-Cook Medical Inc
  • 제조사 주소
    Wilson-Cook Medical Inc, 4900 Bethania Station Rd, & 5951 Grassy Creek Blvd., Winston-Salem NC 27105
  • Source
    USFDA