Events

Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of components including blades, gowns, needles, sponges, towels, syringes, gloves, etc. || All products could have the WINDSTONE MEDICAL INC. label or the CARDIO-PAK label. || MAJOR PACK 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Windstone 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
    25830
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0753-03
  • 사례 시작날짜
    2003-03-25
  • 사례 출판 날짜
    2003-04-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2003-09-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26554
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
  • 원인
    Product has latex free symbol on package, yet contains latex components.
  • 조치
    On 3/25/03 the firm contacted their customers by telephone. This was followed by a letter dated 3/25/03. Enclosed with the letter is a response form for the customer to fill out and return to the firm. Product is to be returned to the firm.

Device

Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and ...
  • 모델명 / 제조번호(시리얼번호)
    Catalog number 002117-000 Lot numbers 000006595, 000006895
  • 의료기기 분류등급
    Cardiovascular Devices
  • 유통
    The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
  • 제품 설명
    Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of components including blades, gowns, needles, sponges, towels, syringes, gloves, etc. || All products could have the WINDSTONE MEDICAL INC. label or the CARDIO-PAK label. || MAJOR PACK
  • Manufacturer
    Windstone Medical, Inc.

Manufacturer

Windstone Medical, Inc.
  • 제조사 주소
    Windstone Medical, Inc., 1602 4th Ave North, Billings MT 59101
  • Source
    USFDA