Events

Compact Absorbers 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Datex - Ohmeda, 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
    36326
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0291-2007
  • 사례 시작날짜
    2006-09-11
  • 사례 출판 날짜
    2006-12-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48422
  • 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
    anesthesia gas absorber - Product Code BSZ
  • 원인
    Certain compact absorbers may have an increased resistance to gas flow due to an improperly manufactured foam filter. the increased resistance can cause an elevated pressure at the ventilator end of the inspiratory circuit, but the pressure at the patient may be reduced. this could result in patient hypoventilation and hypoxia.
  • 조치
    All customers were contacted by letter in September 2006, and provided with a customer reply form. The firm sales some of the Compact Absorbers to distributors and they were asked to notify their Compact Absorber customers. Customers outside the US will be contacted to the end user and then their dealers and distributors. The letter said to immediately discontinue the use of all Compact Absorbers having a lot number as identified (reference codes 427002100 - white to violet color change) and (42700200 - pink to white color change). The affected lot numbers should be isolated and destroyed. Once the Product Verification Form has been received by Fax, Multi-Absorbers or when replacement Compact Absorbers are available will be shipped to customers free of charge.

Device

Compact Absorbers
  • 모델명 / 제조번호(시리얼번호)
    The lot number is always a six-digit number, where the first digits indicate the manufacturing sub-batch during the month and the last three digits indicate the month and year of the manufacture (MMY). The last three digits indicating month and year of manufacture are most significant. For example, a lot number ending in 086 indicates that this lot was manufactured in August 2006.  -All lots manufactured in July, 2006 (076) or earlier are affected.  -Compact Absorbers from lot numbers 133086 and 136086, manufactured in August, 2006, should be isolated and destroyed. All other lots manufactured in August 2006 (086) are acceptable for use.  -All lots manufactured in September 2006 (096) or later are acceptable for use.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Austria, Australia, Belgium, Canada, Croatia, Germany, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Japan, South Korea, Kuwait, Netherlands, Norway, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
  • 제품 설명
    Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF 427002000, Pink to white. Used with GE Healthcare ADU anesthesia systems. GE Healthcare Finland Oy, Helsinki, Finland +358 10 39411.
  • Manufacturer
    Datex - Ohmeda, Inc

Manufacturer

Datex - Ohmeda, Inc
  • 제조사 주소
    Datex - Ohmeda, Inc, 3030 Ohmeda Drive, PO Box 7550, zip 53707-7550, Madison WI 53707-7550
  • Source
    USFDA