Events

Device Recall DERMA PRENE POWDERFREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) 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
    52038
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1586-2009
  • 사례 시작날짜
    2009-05-01
  • 사례 출판 날짜
    2009-07-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-04-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81956
  • 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
    Premature degradation which could result in tearing during use.
  • 조치
    The firm initiated the recall on May 1, 2009 by letter to Health Canada and by letter dated May 4, 2009 to its US and Canadian consignees. The letters described the affected product, issue and actions for customers. The recall was extended to the hospital and clinic level requesting that the product be returned. Direct questions to your Ansell Healthcare Products LLC representative.

Device

Device Recall DERMA PRENE POWDERFREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 0810003405, 0810014405, 0810007905 and 0810015805.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution and Canada.
  • 제품 설명
    Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8515, Size 7 1/2, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. || The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs.
  • Manufacturer
    Ansell Healthcare Products LLC

Manufacturer

Ansell Healthcare Products LLC
  • 제조사 주소
    Ansell Healthcare Products LLC, 1635 Industrial Rd, Dothan AL 36303-5750
  • 제조사 모회사 (2017)
    Ansell Ltd.
  • Source
    USFDA