Gammex 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ansell Healthcare Products LLC 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
    75737
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0893-2017
  • 사례 시작날짜
    2016-10-24
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-10-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Surgeon's gloves - Product Code KGO
  • 원인
    Ansell healthcare products is initiating a voluntary recall involving 15 cases of gammex non latex sensitive surgical gloves because the packaged contents incorrectly included a natural rubber latex surgical glove.
  • 조치
    Ansell Healthcare Products, LLC. sent an Urgent: Voluntary Surgical Glove Recall letter dated October 28, 2016, to all affected customers. The letter identified the problem the product and the action the customer needs to take. Please check your product stock at the warehouse and shelf level in order to advise us directly if any gloves having the recalled lot numbers are found. This information, along with your tracking number, must be communicated to our Customer Service Department by calling 1-800-952-9916, or by returning the attached Response Form to Ansell by fax at 1-800-722-8155, or via email customerserviceus@ansell.com . Returned product will either be replaced or credited without delay. Your Ansell representative will be available to follow up with you regarding any concerns you may have.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot 1607018105
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : PA, FL, NJ, IL and MA.
  • 제품 설명
    Gammex Non-Latex Sensitive Neoprene Surgical Gloves || Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka || Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium || Manufactured for/ Fabrique' pour: || Ansell Healthcare products LLC. || 1635 Industrial Road Dothan, AL 36303, USA || TEL USA- 1-800-952-9916 CAN- 1-844-494-7854 || catalog #20277285
  • Manufacturer

Manufacturer

  • 제조사 주소
    Ansell Healthcare Products LLC, 111 Wood Ave S Ste 210, Iselin NJ 08830-2700
  • 제조사 모회사 (2017)
  • Source
    USFDA