Events

Device Recall Custom 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-1284-2017
  • 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=152820
  • 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 Custom Pack
  • 모델명 / 제조번호(시리얼번호)
    Lot number and expiration date  100084, 10/2/2019 100678, 10/22/2019 100683, 10/13/2019 100700, 9/5/2019 100771, 7/9/2019 100772, 7/23/2019 101188, 9/6/2019 101555, 9/9/2019 84253, 5/12/2018 84254, 5/25/2018 84377, 9/10/2018 84493, 5/28/2018 84494, 5/28/2018 84495, 6/22/2018 84681, 7/22/2018 84682, 7/29/2018 84853, 7/22/2018 84919, 6/3/2018 86006, 8/22/2018 86135, 9/29/2018 86853, 10/31/2018 87162, 8/10/2019 87171, 8/20/2018 87229, 10/5/2018 87582, 12/28/2018 87615, 12/17/2018 88006, 9/23/2018 88227, 9/5/2018 88559, 11/14/2018 88573, 11/12/2018 88574, 11/14/2018 88692, 2/28/2018 88693, 12/9/2018 88899, 11/24/2018 89221, 12/7/2018 89554, 12/9/2018 89555, 1/6/2019 89762, 1/10/2019 94731, 11/12/2018 95058, 1/18/2019 95061, 1/13/2019 95477, 12/7/2018 95510, 1/25/2019 95631, 3/7/2019 95654, 1/10/2019 95874, 6/27/2019 96054, 1/13/2019 96361, 3/10/2019 96458, 1/25/2019 96477, 1/25/2019 96478, 6/23/2019 96834, 6/10/2019 96988,6/9/2019 97000, 6/29/2019 97166, 5/11/2019 97547, 5/7/2019 97820, 6/7/2019 98230, 6/8/2019 98588, 6/7/2019 98753, 6/3/2019 99515, 9/21/2019 99516, 9/30/2019 99564, 9/8/2019 99603, 10/4/2019
  • 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
    Custom Pack, part number AMS4776 || Custom Pack, part number AMS4776(A || Custom Pack, part number AMS5643 || Custom Pack, part number AMS5643(A || Custom Pack, part number AMS6012 || Custom Pack, part number AMS6383 || Custom Pack, part number PSS2135(B || Custom Pack, part number PSS2798(B || Custom Pack, part number PSS2798(C || Custom Pack, part number PSS3463
  • Manufacturer
    Windstone Medical Packaging, Inc.

Manufacturer

Windstone Medical Packaging, Inc.