Events

Device Recall Amerigel Daily Dressing Advanced 3in1 Hydrogel 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Amerx Health Care Corp. 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
    69083
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2641-2014
  • 사례 시작날짜
    2014-07-11
  • 사례 출판 날짜
    2014-09-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-07-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129599
  • 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
    Dressing, wound and burn, hydrogel w/drug and/or biologic - Product Code MGQ
  • 원인
    Not approved labeling claims (antimicrobial and autolytic debridement).
  • 조치
    On July 21, 2014, Amerx Health Care Corporation telephoned all affected customers advising them of the recalled products. During the call the customers were instructed to: 1) Discontinue dispensing the lot(s) and promptly return via parcel post to the Clearwater facility. 2) If you dispose of the product on your own, provide proof of disposal. 3) You will be reimbursed by check or credit memo for returned or disposed goods and postage.

Device

Device Recall Amerigel Daily Dressing Advanced 3in1 Hydrogel
  • 모델명 / 제조번호(시리얼번호)
    Lot codes: 2WD07.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and WV, and the countries of Canada, England, Africa, and Australia.
  • 제품 설명
    Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. || Wound management.
  • Manufacturer
    Amerx Health Care Corp.

Manufacturer

Amerx Health Care Corp.
  • 제조사 주소
    Amerx Health Care Corp., 1300 S. Highland Avenue, Clearwater FL 33756
  • 제조사 모회사 (2017)
    Procyon Corp.
  • Source
    USFDA