Events

Amerigel Saturated Gauze Dressing 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
    69394
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0500-2015
  • 사례 출판 날짜
    2014-12-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130411
  • 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
    Formulation deviation.
  • 조치
    Amerx Health Care Corporation sent an URGENT: DEVICE RECALL letter instructing consignees to examine their inventory and immediately determine if they have any of the Lot numbers on hand and to quarantine the product subject to recall. In addition, if they may have further distributed the product, please notify their customers and/or post the enclosed letter in a visible location for the customer to read. Customers with questions were instructed to call 800-448-9599 or email recall@amerxhc.com. For questions regarding this recall call 727-443-0530.

Device

Amerigel Saturated Gauze Dressing
  • 모델명 / 제조번호(시리얼번호)
    Model # A5002, Lot #s: 05368, 05345, 09282, 10295, 12201, 12303, 12322, 12328, 13100, 13115, 13180
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, 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, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.
  • 제품 설명
    Amerigel Saturated Gauze Dressing || 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