Events

Device Recall SODASORB 48 IND HP 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Darex Container Products Div of W.R. Grace & Co. 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
    25673
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0730-03
  • 사례 시작날짜
    2003-02-11
  • 사례 출판 날짜
    2003-04-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-01-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26317
  • 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
    Absorbent, Carbon-Dioxide - Product Code CBL
  • 원인
    Contaminated with epoxy chips.
  • 조치
    Recalled by letter dated 2/11/03 on W.R. Grace-Conn. letterhead. The accounts were informed that the product was contaminated with trace amounts of material from their processing equipment, which posed no hazard to health. The accounts were requested to return all unopened packages of Sodasorb with the affected lot numbers for replacement.

Device

Device Recall SODASORB 48 IND HP
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers CP01-P124-01, CP01-P124-02, CP01-P124-04 and CP01-P124-05
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide, Canada, the Philippines, Australia, Brazil, Chile, Dominican Republic, Korea and Japan.
  • 제품 설명
    High Performance Sodasorb Carbon Dioxide Absorbent, Diving Grade(18%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorber is depleted; Manufactured by: W.R. Grace & Company, 6050 West 51st Street, Chicago, IL 60638; the product is packaged in 5-gallon pails under the W.R. Grace label
  • Manufacturer
    Darex Container Products Div of W.R. Grace & Co.

Manufacturer

Darex Container Products Div of W.R. Grace & Co.
  • 제조사 주소
    Darex Container Products Div of W.R. Grace & Co., 6050 W. 51st Street, Chicago IL 60639
  • Source
    USFDA