Events

Device Recall General 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-1305-2017
  • 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=152848
  • 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 General Pack
  • 모델명 / 제조번호(시리얼번호)
    Lot number and expiration date  100415, 9/23/2019 100737, 9/30/2019 100981, 10/20/2019 101069, 9/6/2019 101739, 10/19/2019 101816, 10/14/2019 83797, 5/12/2018 84203, 5/26/2018 84668, 5/17/2018 84793, 2/3/2019 85141, 6/8/2018 85421, 7/28/2018 85504, 8/30/2018 86008, 7/8/2018 86260, 9/9/2018 86481, 9/5/2018 86586, 9/27/2018 86774, 8/8/2018 86837, 9/12/2018 87291, 9/30/2018 87456, 9/30/2018 87754, 1/7/2019 88321, 9/6/2018 88648, 12/29/2018 88657, 12/2/2018 88764, 10/8/2018 89333, 12/25/2018 89429, 12/29/2018 94713, 12/14/2018 94739, 1/25/2019 94783, 12/16/2018 95286, 11/12/2018 95349, 1/10/2019 95432, 1/24/2019 95459, 1/21/2019 95928, 1/23/2019 95999, 3/9/2019 96009, 1/7/2019 96501, 1/6/2019 96934, 5/30/2019 97201, 5/5/2019 97338, 5/13/2019 97459, 6/4/2019 97854, 6/14/2019 98176, 6/29/2019 98263, 6/11/2019 98677, 6/3/2019 99291, 6/12/2019 99385, 6/11/2019 99682, 6/29/2019 99712, 6/5/2019 99889, 9/4/2019 99926, 9/27/2019
  • 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
    General Pack, part number AMS2967(A || General Pack, part number AMS3239(A || General Pack, part number AMS3709(B || General Pack, part number AMS5341 || General Pack, part number AMS5694
  • Manufacturer
    Windstone Medical Packaging, Inc.

Manufacturer

Windstone Medical Packaging, Inc.