Events

Device Recall SCANLAN Premier Jacobson Micro Scissors 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Scanlan International 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
    32790
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1532-05
  • 사례 시작날짜
    2005-07-27
  • 사례 출판 날짜
    2005-09-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-12-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40825
  • 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
    Implantable Pacemaker Pulse-Generator - Product Code DXY
  • 원인
    Some scissors purchased before may 1, 2005 may not perform properly. they may have a crack in the blade that could break.
  • 조치
    Urgent Medical Device Recall letters were sent 07/27/05 to distributors asking them to retrieve affected product from their customers and return it to Scanlan International, Inc., St. Paul, MN. Distributors are asked to complete and return a Return Fax Form by August 4, 2005 to acknowledge receipt of letter.

Device

Device Recall SCANLAN Premier Jacobson Micro Scissors
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: U7A, U7B, U7C, U7D, V7A, V7B, V7C, V7D, and W7A. The lot numbers are located on the inside shank of the instrument near the fulcrum. Please note: If there is a ''T'' on the inside shank of one of the spring handles, the instrument is not included in this recall.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    worldwide. Including the United States and countries such as: Austria, Canada, China, Denmark, Finland, Germany, Greece, India, Italy, Japan, Korea, Malaysia, The Netherlands, Switzerland and Taiwan.
  • 제품 설명
    SCANLAN Premier Jacobson Micro Scissors, spring style, round handle, V-neck, 125-degree angled nano blades, 6-1/2'', 16.5 cm. Catalog no. 7007-598.
  • Manufacturer
    Scanlan International Inc

Manufacturer

Scanlan International Inc
  • 제조사 주소
    Scanlan International Inc, One Scanlan Plaza, Saint Paul MN 55107
  • Source
    USFDA