Events

Device Recall Bemis/ Medline 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bemis Health Care,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
    36160
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0170-2007
  • 사례 시작날짜
    2006-08-23
  • 사례 출판 날짜
    2006-11-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-01-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48102
  • 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
    sharps container - Product Code MMK
  • 원인
    The 5 quart wall safes are shipped as two pieces (bottom & top) that customers are unable to assemble because of excess warp in the back wall of the container.
  • 조치
    Letters were mailed to consignees August 23, 2006 describing the product with lots and model numbers. Customers were asked to have product destroyed rather than returned to Bemis. Enclosed with the letter was a Recall Acknowledgement/Destroy in field form that they were instructed to fax to BEMIS. A second letter was sent out to the non-responders on September 13, 2005.

Device

Device Recall Bemis/ Medline
  • 모델명 / 제조번호(시리얼번호)
    BEMIS: Model 7H150 020 includes lot 20060001 to 20060016;  BEMiS: Model 7H150 030 includes lot 20050006, 20060001 to 20060008;  BEMIS: Model 7H150 040 includes lot 20060001 to 20060008;  Medline Model 7H950 030 includes lot 20050027, 20060001 to 20060008.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Canada.
  • 제품 설명
    5 Qt. Wallmount Sharps Container, Model 150, Regular Size; colors 202 Beige, 030 Red, 040 Yellow, 24 count containers; Made in USA for: Medline Industries; BEMIS label has Manufactured by Bemis Mtg. Co., Sheboygan Falls, WI.
  • Manufacturer
    Bemis Health Care,Inc

Manufacturer

Bemis Health Care,Inc
  • 제조사 주소
    Bemis Health Care,Inc, 300 Mill St, Sheboygan Falls WI 53085-1807
  • Source
    USFDA