Events

Device Recall Hand Tray 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Windstone Medical Packaging, 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
    76280
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1312-2017
  • 사례 시작날짜
    2017-01-11
  • 사례 출판 날짜
    2017-02-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152855
  • 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
    Light, surgical, ceiling mounted - Product Code FSY
  • 원인
    The medtronic cover light handle disposable gloves of the custom aligned medical solutions (ams) kits were recalled because gloves may contain splits or holes compromising sterility.
  • 조치
    AMS notified their consignees by Email, Fax, and Phone on 11/11/2017. AMS sent the notification letter, dated January 11, 2017, and provided yellow stickers "Recall Notice" to customers. They are advised to over-label the affected AMS kits at their facilities. Customers were instructed to place sticker in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date on a kit. Customers with questions can call Vicki Davis at 321-527-7714 or send email to vdavis@alignedmedicalsolutions.com.

Device

Device Recall Hand Tray
  • 모델명 / 제조번호(시리얼번호)
    Lot number and expiration date  84418, 1/30/2017 85478, 5/15/2017 85479, 5/21/2017 86212, 1/27/2017 86213, 1/27/2017 86630, 1/14/2017 87353, 1/24/2017 87946, 1/30/2017 88345, 2/22/2017 89564, 2/19/2017 94774, 1/17/2017 95066, 1/30/2017 95322, 1/25/2017 95854, 2/18/2017 96363, 2/10/2017 96634, 2/7/2018 97251, 2/7/2018 97325, 2/18/2018 98448, 2/10/2018 98449, 5/12/2018 98450, 10/24/2018 98451, 10/24/2018 98452, 10/31/2018 98453, 10/30/2018 98576, 10/20/2018 98577, 4/16/2019
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
  • 제품 설명
    Hand Tray, part number PSS2365(F || Hand Tray, part number PSS2365(G
  • Manufacturer
    Windstone Medical Packaging, Inc.

Manufacturer

Windstone Medical Packaging, Inc.