Events

Device Recall SODASORB 48 IND H MED 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
    31687
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0850-05
  • 사례 시작날짜
    2005-03-31
  • 사례 출판 날짜
    2005-05-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-07-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38349
  • 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
    Both lots were found to be out of specification due to an elevated level of small particles (fines).
  • 조치
    Recall letters dated 3/30/05 were sent to the accounts via DHL on 3/31/05, informing them that the two lots did not undergo final QC testing prior to shipment and do not meet finished product specifications. The accounts were requested to check their inventory for the affected lots, discontinue use and place it on hold pending return to W.R. Grace for replacement. Any questions were directed to the Sodasorb Recall Coordinator at 1-877-327-3987.

Device

Device Recall SODASORB 48 IND H MED
  • 모델명 / 제조번호(시리얼번호)
    pre-paks lot CR10-P115-14, exp. 10/2006, and 5-gallon pail lot CR09-P115-30, exp. 9/2006
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    California, Connecticut, Pennsylvania, Maine, Massachusetts, MIssissippi, New Hampshire, New Jersey, New York, Vermont, Virginia and West Virginia
  • 제품 설명
    Sodasorb Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorber is depleted; Manufactured by: W.R. Grace & Co. - Conn., 6050 West 51st St., Chicago, IL 60638; the product is packaged in pre-paks(pre-filled 2.5 lb. canisters, 12 per carton) and 5-gallon pails
  • 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 St, Chicago IL 60638-1405
  • Source
    USFDA