Events

DriSate 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Rockwell 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
    79878
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1869-2018
  • 사례 시작날짜
    2018-04-07
  • 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=163799
  • 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 concentrate for hemodialysis (liquid or powder) - Product Code KPO
  • 원인
    A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
  • 조치
    Removal notification involved one customer and two facilities. The two facilities receiving the DR-145 kit lot were contacted directly via phone, email, and issuance of a RGA to return the product. Stock retrieval was completed by 4/7/17. See attached email and RGA. Communication was already completed and stock was retrieved. Discard and/or return via RGA provided The complaint documented a stock reconciliation in the complaint and all units were accounted for. The two customer facilities involved responded directly Affected kits were reworked to remove and replace the nonconforming dextrose bag. For further questions, please call (864) 849-0530.

Device

DriSate
  • 모델명 / 제조번호(시리얼번호)
    Lot 28562-0220171
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the state of NY
  • 제품 설명
    DriSate¿ Product Code DR-145 || The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.
  • Manufacturer
    Rockwell Medical, Inc

Manufacturer

Rockwell Medical, Inc
  • 제조사 주소
    Rockwell Medical, Inc, 30142 S. Wixom Rd., Wixom MI 48393-3440
  • 제조사 모회사 (2017)
    Rockwell Medical, Inc.
  • Source
    USFDA