Events

Device Recall Hand 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-1311-2017
  • 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=152854
  • 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 Pack
  • 모델명 / 제조번호(시리얼번호)
    Lot number and expiration date  100610, 8/6/2018 84646, 5/12/2017 84692, 7/28/2017 84730, 5/18/2017 84851, 6/1/2017 84859, 2/28/2017 85509, 7/1/2017 86309, 8/26/2018 86748, 8/17/2018 86839, 8/2/2018 86937, 10/14/2017 87631, 10/5/2017 87866, 9/15/2018 88208, 4/6/2017 88209, 7/31/2017 88266, 10/29/2018 88267, 1/5/2020 88279, 1/3/2019 88402, 11/2/2017 88875, 10/31/2017 89734, 12/16/2017 94987, 3/21/2018 95112, 2/2/2018 96198, 2/10/2018 96608, 1/7/2018 97288, 2/7/2018 97796, 5/6/2018 98564, 3/19/2018 99383, 5/11/2018
  • 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
    Hand Pack, part number AMS3640 || Hand Pack, part number AMS4213(A || Hand Pack, part number AMS4311(A || Hand Pack, part number AMS5343 || Hand Pack., part number PSS1843(A
  • Manufacturer
    Windstone Medical Packaging, Inc.

Manufacturer

Windstone Medical Packaging, Inc.