Events

Vacuum Collection Bottle 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ohio Medical Corporation 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
    53192
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0089-2010
  • 사례 시작날짜
    2009-09-21
  • 사례 출판 날짜
    2009-10-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84896
  • 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
    Bottle, collection, vacuum - Product Code KDQ
  • 원인
    The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. the recommended cleaning of the bottles include use of ammonia and autoclaving, which may have an adverse impact on polycarbonate.
  • 조치
    Ohio Medical Corporation issued recall letters beginning September 17, 2009. Consignees were informed of the affected product and requested to return affected collection bottles to the firm. The accounts were requested to complete and return the enclosed acknowledgement form, indicating the number of affected units on hand, to obtain a returned material authorization for the return of the recalled bottles and their replacement. For further information, contact Ohio Medical Quality Assurance Manager, Anita Christ, at 847-855-6270.

Device

Vacuum Collection Bottle
  • 모델명 / 제조번호(시리얼번호)
    The bottles have a date stamp on the bottom which consists of a clock dial and a two digit number in the middle with an arrow pointing to the hour number on the dial. The codes 07 -> 5 and 08 ->10 are affected.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, Canada, Chile, Costa Rica, Cyprus, Egypt, El Salvador, Greece, Hong Kong, India, Israel, Japan, Jordan, Korea, Kuwait, Malaysia, Netherlands, Oman, Paraguay, Philippines, Qatar, Saudi Arabia, Singapore, Thailand, Turkey, United Kingdom and Venezuela.
  • 제품 설명
    Vacuum Collection Bottle, 1/2 gallon (1300 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0301-600 (6700-0206-500); the bottles are sold alone and with various cap & float assemblies including: || 0321-7986-801 - Bottle with Straight Wall Bracket, Cap & Float; || 6700-0019-800 - Bottle with Floor Bracket, Cap & Float; || 6700-0024-800 - Bottle with V Wall Bracket, Cap & Float. || The collection bottles are part of a suction bottle assembly which is designed to collect various body fluids.
  • Manufacturer
    Ohio Medical Corporation

Manufacturer

Ohio Medical Corporation
  • 제조사 주소
    Ohio Medical Corporation, 1111 Lakeside Dr, Gurnee IL 60031
  • Source
    USFDA