Events

Device Recall Arthroscopy Pack 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-1261-2017
  • 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=152791
  • 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 Arthroscopy Pack
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers and Expiration Dates  83622, 5/19/2018 84374, 5/24/2018 84729, 5/17/2017 84897, 5/26/2018 84946, 6/24/2017 85171, 6/9/2018 85363, 7/20/2017 85548, 7/15/2018 85696, 8/22/2018 85698, 7/21/2017 86510, 9/29/2018 86687, 9/5/2018 86889, 7/11/2017 86909, 9/12/2018 87156, 8/1/2018 87157, 9/5/2018 87159, 10/23/2017 87289, 10/17/2017 87978, 10/31/2017 88401, 10/7/2017 88549, 10/28/2017 88656, 12/7/2017 89219, 12/22/2017 89904, 1/23/2017 94742, 12/29/2017 95143, 12/4/2017 95284, 2/2/2018 95315, 2/20/2018 95840, 2/13/2018 96006, 1/7/2018 96469, 2/27/2018 96631, 1/8/2018 96821, 3/25/2018 96931, 2/1/2018 97751, 3/2/2018 98923, 3/20/2018 98971, 9/19/2018
  • 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
    Arthroscopy Pack, part number AMS2938 || Arthroscopy Pack, part number AMS3639 || Arthroscopy Pack, part number AMS4765 || Arthroscopy Pack, part number PSS1799 || Arthroscopy Pack, part number PSS1845(A
  • Manufacturer
    Windstone Medical Packaging, Inc.

Manufacturer

Windstone Medical Packaging, Inc.