Events

Device Recall Amerigel 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
    71161
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1797-2015
  • 사례 시작날짜
    2015-02-25
  • 사례 출판 날짜
    2015-06-12
  • 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=136323
  • 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
    Nonapproved labeling claims (sterile).
  • 조치
    On March 9, 2015 the firm contacted its customers via telephone. Within that conversation the firm asked its customers to examine their inventory to determine if they have any of the affected lot numbers on hand and notify the firm for an immediate product substitution, credit or refund. Customers were asked to discontinue dispensing any product on hand, and notify any customers that the product may have been further distributed to. The firm also asked that the response form be completed and returned. If no contact was made via telephone, the firm sent a certified letter asking the firm(s) to do the same actions as the phone request. If you have any questions please call 1-800-448-9599 or e-mail marketcorrection@amerxhc.com.

Device

Device Recall Amerigel
  • 모델명 / 제조번호(시리얼번호)
    ALL Lots - 11406, 11414, 12439, 12466, and 02521.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.
  • 제품 설명
    Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. || 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