Events

Device Recall Upper Extremity 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-1378-2017
  • 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=152933
  • 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 Upper Extremity Pack
  • 모델명 / 제조번호(시리얼번호)
    Lot number and expiration date  100052, 9/16/2018 84369, 6/20/2017 84721, 6/26/2017 84951, 6/21/2017 85377, 7/26/2017 86594, 10/8/2017 86595, 10/11/2017 87312, 10/24/2017 87990, 10/6/2017 88277, 10/26/2017 88668, 11/1/2017 89203, 12/16/2017 89605, 12/17/2017 94907, 12/28/2017 94968, 12/5/2017 95303, 2/27/2018 95476, 2/20/2018 96326, 2/1/2018 96619, 2/10/2018 96788, 2/1/2018 96950, 1/5/2018 97302, 3/20/2018 97596, 4/28/2018 97819, 3/15/2018 98048, 3/24/2018 98529, 5/30/2018 98710, 6/10/2018 98945, 5/24/2018 98946, 6/7/2018
  • 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
    Upper Extremity Pack, part number AMS4670 || Upper Extremity Pack, part number AMS4670(A
  • Manufacturer
    Windstone Medical Packaging, Inc.

Manufacturer

Windstone Medical Packaging, Inc.