Events

Device Recall ElastoGel Wound Dressing & ElastoGel Plus Wound Dressing (with Tape) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Southwest Technologies 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
    35051
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0841-06
  • 사례 시작날짜
    2006-03-27
  • 사례 출판 날짜
    2006-05-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-12-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45195
  • 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, Drug - Product Code FRO
  • 원인
    The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit.
  • 조치
    Recall letters were sent to all direct accounts via certified mail on 3/27/2006. The consignees were requested to return any affected product on hand and if the product was further distributed, notify their customers.

Device

Device Recall ElastoGel Wound Dressing & ElastoGel Plus Wound Dressing (with Tape)
  • 모델명 / 제조번호(시리얼번호)
    Elasto-Gel Plus, Product DR8050, Lot 111004A. Elasto-Gel, Product DR8000LV, Lot 110904A. Elasto-Gel, Product No. DR8000, Lot 102504A.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Product was distributed to direct accounts in the United States and Belgium.
  • 제품 설명
    Elasto-Gel Wound Dressings, 3 product codes: DR8050, DR 8000, and DR 8000LV (for foreign distribution only), 4'' x 4'', Sterile, each package contains 1 wound dressing, 5 packages per intermediate box, 20 intermediate boxes (100 pkgs) per case. The label shows the product is Manufactured by Southwest Technologies, Inc., North Kansas City, MO.
  • Manufacturer
    Southwest Technologies Inc

Manufacturer

Southwest Technologies Inc
  • 제조사 주소
    Southwest Technologies Inc, 1746 E Levee St, N Kansas City MO 64116-4404
  • Source
    USFDA