Events

Acticoat 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smith And Nephew, Inc. Wound Management Division 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
    26318
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0016-04
  • 사례 시작날짜
    2003-04-15
  • 사례 출판 날짜
    2003-10-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27499
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
  • 원인
    Product may not meet the established stability specification before the end of labeled expiry date.
  • 조치
    A Recall notification with a Response Form was mailed first class with return reciept requested on April 15, 2003 to direct accounts. The recall was to the wholesale distributor level only. The accounts were asked to check their stock immediately and to return recalled product to the Recalling Firm in Largo, FL. Non responding accounts were sent follow-up Recall Notifications letters.

Device

Acticoat
  • 모델명 / 제조번호(시리얼번호)
    021022A, 021023A, 021118A, 030106A, 030107A
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 유통
    The recalled devices were distributed to 81 direct wholesalers or medical facilities nationwide. There were no direct international or government/military accounts.
  • 제품 설명
    Acticoat* Moisture Control Dressing, Product Code 20211, Distributed by Smith & Nephew, Inc., Wound Management Division, 11775 Starkey Road, Largo, FL 33773
  • Manufacturer
    Smith And Nephew, Inc. Wound Management Division

Manufacturer

Smith And Nephew, Inc. Wound Management Division
  • 제조사 주소
    Smith And Nephew, Inc. Wound Management Division, 11775 Starkey Rd, Largo FL 33773
  • Source
    USFDA