Events

Device Recall Dermabond Topical Skin Adhesive 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ethicon, 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
    57884
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1496-2011
  • 사례 시작날짜
    2011-02-02
  • 사례 출판 날짜
    2011-03-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97665
  • 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
    Topical Skin Adhesive - Product Code KGX
  • 원인
    Some units of dermabond topical skin adhesive and dermabond propen topical skin adhesive contain discolored product.
  • 조치
    Ethicon sent their recall letters with business reply cards attached on February 2, 2011 via UPS overnight mail. Customers are informed of the issue and asked to return the attached business reply card.

Device

Device Recall Dermabond Topical Skin Adhesive
  • 모델명 / 제조번호(시리얼번호)
    Product code Lot # Exp. Date DHV12 CJE222 7/31/2012 DHV12 CJP430 7/31/2012 DHV12 CJR302 7/31/2012 DHV12 CJR488 7/31/2012 DHV12 CJR604 7/31/2012 DHV12 CKB001 7/31/2012 DHV12 CKB157 8/31/2012 DHV12 CKB231 8/31/2012 DHV12 CKB492 8/31/2012 DHV12 CKB584 8/31/2012 DHV12 CKB681 8/31/2012 DHV12 CKB820 8/31/2012 DHV12 CKB966 8/31/2012 DHV12 CKE195 8/31/2012 DHV12 CKE335 8/31/2012 DHV12 CKE336 8/31/2012 DHV12 CKE655 8/31/2012 DHV12 CKE842 8/31/2012 DHV12 CKP038 8/31/2012 DHV12 CKP201 8/31/2012 DHV12 CKP358 8/31/2012
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution, including USA, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Repub, Chile, China, Denmark, Dominican Repub, Egypt, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, ireland, Israel, italy, Japan, Korea, Lithuania, Luxembourg, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Palestine, Puerto Rico, Reunion, Russia, Senegal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Ukraine, and Venezuela.
  • 제품 설명
    Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc.
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • 제조사 주소
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA