Events

Device Recall Fresenius 2008K Dialysate Delivery System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fresenius Medical Care Holdings, 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
    70574
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1551-2015
  • 사례 시작날짜
    2015-02-20
  • 사례 출판 날짜
    2015-04-29
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135408
  • 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
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • 원인
    The acetate value for granuflo on the select concentrate screen should be 8meq/l but it is displayed as 4meq/l. the correct value is shown on the dialysate screen.
  • 조치
    The firm, Fresenius Medical Care, sent an "URGENT - MEDICAL DEVICE CORRECTION" letter dated February 19, 2015 to its Consignees via certified mail on February 26, 2015. The letter describes the product, problem and actions to be taken. The consignees were instructed to sign and return the attached "Reply Form" via fax to: 781-699-9769 Attn: Quality Department or Scan and E-mail to: NOTIFYRA@fmc-na.com to confirm that they received and understand the customer notification. The firm will be providing a software update and stated that in the near future, your local clinic will be contacting you about installing the software update. If you have any questions pertaining to this Customer Notification, please contact your local clinic, 800-227-2572 or the Corrections and Removals Manager at 800-662-1237.

Device

Device Recall Fresenius 2008K Dialysate Delivery System
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 0K0S-0009 0K0S-0011- 0015 0K0S-0018 0K0S-0019 0K0S-0021- 0028 0K0S-0030- 0032 0K0S-0034- 0036 0K0S-0038- 0040 0K0S-0042 0K0S-0044- 077 0K0S-0080- 278 0K0S-0280- 285 0K0S-0287- 478 0K0S-0480- 552 0K0S-0554- 677 0K0S-0679- 884 0K0S-0886- 900 0K0S-0902- 916 0K0S-0918 0K0S-0920 0K0S-0921 0K0S-0923- 926 0K0S-0928- 934 0K0S-0936- 942 0K0S-0944- 958 0K0S-0961 0K0S-0962 0K0S-0964- 991 0K0S-0993- 0999 1K0S-1001- 4999 2K0S-5000- 9999 2K0S-A000- A999 2K0S-B000- B999 3K0S-C000- C999 3K0S-D000- D999 3K0S-E000- E999 3K0S-F000- F999 3K0S-G000- G999  3KOS-H000- H999 4H0S-J275 4K0S-J000- J999 4K0S-K000- K999 4K0S-L000- L999 4K0S-M000- M999 4K0S-N000- N999 4K0S-P000- P999 4K0S-Q000- Q999 4K0S-R000- R999 4K0S-S000- S999 4K0S-T615 4KK0S-Q907 50S-W536 5K0S-000A- 999D 5K0S-T000- T999 5K0S-U000- U999 5K0S-V000- V999 5K0S-W000- W999 5K0S-X000- X999 5K0S-Y011- Y999 5K0S-Z000- Z999 5K0-Y176 6K0S-000E- 999E 6K0S-000F- 999E 6K0S-000G- 999E 6K0S-000H- 999H 6K0S-000J- 999J 6K0S-000K- 999K 6K0S-000L- 999L 6K0S-000M- 999M 6K0S-000N- 999N 6K0S-000P- 999P 6K0S-000Q- 999Q 6K0S-000R- 999R 6K0S-000S- 999S 6K0S-000T- 159T 7K0S100001- 115591 7KOS103444 7KOS103556 7KOS104151 7KOS104219 7KOS104293 7KOS104318 8K0S115592- 121299 8K0S121301- 126597 8K0S1269573 8K0S127201- 130767 8K0S130769 8K0S130770- 131327 8K0S131329 8K0S131331 8K0S131333- 1365 8K0S131406- 1411 8K0S131417-1419 8K0S131426 8K0S131448
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.
  • 제품 설명
    2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC and Diasafe Plus - Spanish; 190302 2008K System w/ OLC and Short Cab; 190306 2008K System w/ Short Cabinet; 190373 2008K System w/ Short Cabinet; 190305 2008K System w/o Diasafe; 190301 2008K System w/o HP; 190372 2008K System w/o HP; 190303 2008K System w/o OLC and Diasafe; 190304 2008K System w/o OLC and Diasafe and HP; 190452 2008K System w/o OLC and w/ Diasafe Plus; 190303 2008K W/O OLC and DIASAFE W/ HEPARIN PUMP; 190304 2008K W/O OLC and DIASAFE W/O HEPARIN PUMP || The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.

Manufacturer

Fresenius Medical Care Holdings, Inc.
  • 제조사 주소
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • 제조사 모회사 (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA