Events

Device Recall Basic 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-1267-2017
  • 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=152802
  • 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 Basic Pack
  • 모델명 / 제조번호(시리얼번호)
    Lot number and expiration date  100394, 9/15/2019 100593, 9/21/2019 100594, 10/5/2019 101063, 10/15/2019 101304, 10/23/2019 83725, 6/8/2018 84749, 9/11/2018 85159, 8/1/2018 85635, 8/6/2018 85810, 7/19/2018 86252, 9/2/2018 86440, 8/7/2018 86859, 8/18/2018 86939, 11/22/2018 87105, 9/15/2018 87269, 9/30/2018 87351, 9/15/2018 87447, 11/11/2018 87942, 9/23/2018 88172, 12/3/2018 88282, 9/7/2018 88368, 9/5/2018 88846, 12/11/2018 88887, 12/7/2018 89004, 10/8/2018 89160, 12/1/2018 89438, 11/22/2018 89512, 10/9/2018 89716, 1/9/2019 89743, 12/3/2018 89811, 12/1/2018 94572, 12/15/2018 94705, 12/15/2018 94751, 1/4/2019 94853, 1/27/2019 94935, 1/25/2019 95293, 1/26/2019 95412, 1/25/2019 95936, 1/11/2019 95974, 5/29/2019 96023, 1/16/2019 96255, 1/2/2019 96410, 3/7/2019 96566, 3/9/2019 96678, 5/24/2019 96913, 5/22/2019 97124, 5/12/2019 97410, 6/3/2019 97577, 5/1/2019 97780, 6/15/2019 98017, 6/29/2019 98312, 6/24/2019 98478, 6/29/2019 98502, 6/6/2019 98663, 6/28/2019 98633, 6/30/2019 99172, 6/12/2019 99581, 6/27/2019 99703, 9/27/2019 99843, 9/30/2019 99887, 9/11/2019 99913, 9/23/2019
  • 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
    Basic Pack, part number AMS1868(B || Basic Pack, part number AMS2608(A || Basic Pack, part number AMS3861 || Basic Pack, part number AMS4309 || Basic Pack, part number PSS1833 || Basic Pack, part number PSS1833(A || Basic Pack, part number PSS1848(A
  • Manufacturer
    Windstone Medical Packaging, Inc.

Manufacturer

Windstone Medical Packaging, Inc.