Events

Device Recall NxStage Dialysate Sack (SAK) with Concentrate 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 NxStage Medical, 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
    68354
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1860-2014
  • 사례 시작날짜
    2014-05-14
  • 사례 출판 날짜
    2014-06-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127456
  • 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
    Dialysate Subsystem, proportioning - Product Code FKR
  • 원인
    Sak dialysate concentrate contain aluminum levels which exceed internal product specification.
  • 조치
    NxStage issued Initial recall letter dated 5/14/14 to dialysis centers. An error was noted and an updated letter dated 5/15/14 was resent to dialysis centers. The updated 5/15/14 letter was emailed to all current active PureFlow SL patients who had provided an email address followed by UPS next business day letter sent to all current active PureFlow SL patients. Accounts are requested to examine inventory and remove product. Contact NxStage Customer Service to arrange for return of all affected product and for replacement product to be sent. If you have any questions or comments, please feel free to contact NxStage Customer Service at 1-866-NXSTAGE (1-866-697-8243).

Device

Device Recall NxStage Dialysate Sack (SAK) with Concentrate
  • 모델명 / 제조번호(시리얼번호)
    Lot code: 40179126 40179125 40179108 40179036 40179035 31279119 3057923 3057907 3047927
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
  • 제품 설명
    NxStage Dialysate Sack (SAK) with Concentrate || for Use with PureFlow SL || REF: SAK-307 || Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, || Chloride 105, Glucose (mg/dL) 100 || Batch Size (liters) 50 || The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.
  • Manufacturer
    NxStage Medical, Inc.

Manufacturer

NxStage Medical, Inc.
  • 제조사 주소
    NxStage Medical, Inc., 350 Merrimack Street, Lawrence MA 01843-1748
  • 제조사 모회사 (2017)
    Nxstage Medical Inc
  • Source
    USFDA