Events

Device Recall Subsystem, proportioning 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
    79185
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0811-2018
  • 사례 시작날짜
    2018-01-29
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161554
  • 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
    Subsystem, proportioning - Product Code FKR
  • 원인
    May contain endotoxin levels which have been confirmed to exceed the ansi/aami quality standard dialysis fluid of 0.5 eu/ml when used to prepare product.
  • 조치
    On January 29, 2018 Product Recall Notices & Recall Reply Forms included were emailed to those patients for whom the firm had an email address. Hard copy letters were sent via UPS second day air to patients for whom NxStage did not have an email address. All Dialysis centers were contacted via email. In addition to the active patients and dialysis center consignees of affected product, recall letters were also emailed to the Dialysis Center Home Training Nurse Manager for all active or dropped patients who were shipped affected product, and corporate contacts for national dialysis accounts. Customers are advised to inspect inventory, quarantine, discontinue use and return product. Customers are also encouraged to return the completed Recall Reply Form. Contact NxStage Customer Service to arrange for return of all affected product and for replacement product to be sent. Customers with questions may call Customer Service at 1-866-697-8243.

Device

Device Recall Subsystem, proportioning
  • 모델명 / 제조번호(시리얼번호)
    SAK-301- Lot # 70879245, Exp Date 7/11/2019 SAK-302- Lot # 71079056, Exp Date 7/30/2019 SAK-303- Lot #'s 70879181 & 70879224,  SAK-304- Lot #'s 70779236, 70879045, 70879105, 70879220 & 70979066, Exp Date 7/8/2019 SAK-306- Lot # 70979110, Exp Date 7/24/2019 SAK-307- Lot #'s 70879187 & 71079144, Exp Date 8/27/2019 SAK-402- Lot # 70879235, Exp Date 7/11/2019 SAK-405- Lot #'s 70779202 & 70879233, Exp Date 7/9/2019 SAK-406- Lot #'s 70979253, Exp Date 7/29/2019 SAK-407- Lot #'s 70879236 , Exp Date 7/11/2019
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and to the countries of : United Kingdom & Spain
  • 제품 설명
    NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070 || Hemodialysis systems and accessories
  • 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