Events

PowderFree Latex Surgical Gloves 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
    57269
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0621-2011
  • 사례 시작날짜
    2010-09-03
  • 사례 출판 날짜
    2010-12-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-11-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95711
  • 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
    Open package seams on sterile gloves.
  • 조치
    The firm, Ansell, sent a letter dated September 3, 2010 to all customers. The letter described the product, problem and actions taken. An Ansell representatives will contact the customer to remove the gloves bearing the noted lot number from their facility; Ansell will ensure that the gloves removed will be replaced shortly with products from a different manufacturing batch and the recall was extended to the retail (hospital and clinic) level requesting that the product be returned. If you have any questions, contact US (334) 615-2563, international telephone 01.34.24.52.52 and email: infofrance@eu.ansell.com.

Device

PowderFree Latex Surgical Gloves
  • 모델명 / 제조번호(시리얼번호)
    Lot 1003006005
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    International distribution only: France and Germany
  • 제품 설명
    ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5¿, Sterile R, CE 0086, EC REP Ansell (UK) Ltd., Tamworth, Staffordshire, B79 7UL UK, Ansell Lanka (pvt) Ltd., Biyagama Export Processing Zone, Biyagama, Sri Lanka || Intended use: Surgical Gloves
  • 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