Events

Device Recall Zee Clear Vinyl Medical Examination Gloves, Large 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cypress Medical 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
    60552
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0680-2012
  • 사례 시작날짜
    2011-11-15
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-10-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105791
  • 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
    Vinyl patient examination glove - Product Code LYZ
  • 원인
    The gloves fail to meet the performance requirements of 21 cfr 800.20 for leakage defects.
  • 조치
    Cypress Medical telephoned the accounts and then sent Urgent Voluntary Medical Device Recall letters dated November 14, 2011, to all affected customers. The letter informed them that the lot of gloves did not meet certain release specifications and that some of the gloves may not provide an effective barrier to infectious material. Customers were requested to cease distribution of the affected product, quarantine the gloves, and contact Cypress Medical's customer service department at 800-334-3646 for a returned goods authorization, return instruction and credit. The accounts were also requested to notify their customers of the recall, and to complete and return the enclosed reply form. For questions regarding this recall call 815-385-0100.

Device

Device Recall Zee Clear Vinyl Medical Examination Gloves, Large
  • 모델명 / 제조번호(시리얼번호)
    Zee Part No.: 3062, lot number CZA04-22
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including California, Indiana, New York and Texas
  • 제품 설명
    Zee Clear Vinyl Medical Examination Gloves, Powder Free, Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3062 || Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants
  • Manufacturer
    Cypress Medical Products LLC

Manufacturer

Cypress Medical Products LLC
  • 제조사 주소
    Cypress Medical Products LLC, 1202 S Il Route 31, Mchenry IL 60050
  • 제조사 모회사 (2017)
    Mckesson Corporation
  • Source
    USFDA