Device Recall Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, PowderFree, Medium Size, 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medline Industries 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
    57988
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1553-2011
  • 사례 시작날짜
    2011-02-03
  • 사례 출판 날짜
    2011-03-04
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-03-19
  • 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
    Vinyl patient examination glove - Product Code OIG
  • 원인
    The recall was initiated because the affected lot, lot number jcu004958569, of gloves did not meet the requirements for the water-leak test.
  • 조치
    MEDLINE INDUSTRIES, INC. sent a RECALL NOTICE IMMEDIATE ACTION REQUIRED letter by US Mail on February 10, 2011, to all affected cusomters. The letter identified the product, the problem, and the action to be taken by the customer. The customers were instructed to: 1. Immediately quarantine ALL inventory of the affected lot for return to Medline. 2. Complete the attached recall verification form. Please complete this form EVEN IF you have none of the affected lot in stock. 3. Fax or email the completed form to Medline. The email address is Recalls@Medline.com or faxed the form to 866-767-1290. Customers with questions regarding the recall were instructed to contact Medline at 1-866-359-1704 or via e-mail at Recalls@Medline.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: JCU04958569
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including CA, HI, and NV.
  • 제품 설명
    Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Medium Size, Catalog Number: MSV402P, Lot Number: JCU04958569
  • Manufacturer

Manufacturer

  • 제조사 주소
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060
  • 제조사 모회사 (2017)
  • Source
    USFDA