Events

Device Recall Fresenius 2008Khome Hemodialysis Machine with bibag 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-1549-2015
  • 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=135406
  • 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 2008Khome Hemodialysis Machine with bibag System
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 0K0S151413 1K0S167702-7721 1K0S169224-244 1K0S170300-311 1K0S171475-499 1K0S171807-849 1K0S172042-061 1K0S172179-199 1K0S172200-205 1K0S172263-266 2K0S174112-149 2K0S174228-246 2K0S175602-628 2K0S179477-501 2K0S180512 2K0S180513 2K0S180516-533 2K0S180542 2K0S180543 2K0S180546 2K0S180628 2K0S180629 2K0S181311-332 2K0S181338-340 2K0S181343-347 2K0S181705-719 3K0S182625-659 3K0S183305-324 3K0S183906-920 3K0S183971-980 3K0S184849-912 3K0S185281-284 3K0S185307-311 3K0S185716-745 3K0S185974-989 3K0S185991-998 3K0S186031-045 3K0S186933-962 3K0S186989-7002 4K0S190280 4K0S190306- 4K0S190307 4K0S190309 4K0S190313 4K0S190319 4K0S190509-543 4K0S190829-854 4K0S191122-141 4K0S191229-234 4K0S191511-513 4K0S191569-572 4K0S191578- 588 4K0S192226-245 4K0S192512 4K0S192514-517 4K0S192520 4K0S192522-524 4K0S192526 4K0S192528 4K0S192529 4K0S192533 4K0S192536 4K0S192538 4K0S192540 4K0S192729 4K0S192735 4K0S-J232 4K0S-J943-J944 4K0S-J947-J952 4K0S-L720-L723 4K0S-M703-M708 4K0S-N151- N160 4K0S-N842- N850 4K0S-N913 4K0S-P288- P299 4K0S-P980- P982 4K0S-Q634- Q643 4K0S-Q688- Q697 4K0S-R079- R083 4K0S-R106- R115 4K0S-R134-R138 4K0S-S703- S722 5K0S-159D- 168D 5K0S-180C- 185C 5K0S-305C- 312C 5K0S-320C- 321C 5K0S-322B 5K0S-354D- 363D 5K0S-451B 5K0S-453B-457B 5K0S-459B- 470B 5K0S-866B- 869B 5K0S-877D- 886D 5K0S-T139 5K0S-T880- T899 5K0S-U131 5K0S-V190- V204 5K0S-X981- X983 5K0S-X986- X990 5K0S-Y001- Y010 5K0S-Z650- Z669 6K0S-004Q 6K0S-006M 6K0S-006Q- 014Q 6K0S-007M- 11M 6K0S-008R- 015R 6K0S-016M- 027M 6K0S-017R- 019R 6K0S-027Q- 031Q 6K0S-050M- 053M 6K0S-056N- 063N 6K0S-085L 6K0S-092L 6K0S-191E- 195E 6K0S-216E- 220E 6K0S-317L- 327L 6K0S-318H- 327H 6K0S-331H- 340H 6K0S-431N- 432N 6K0S-435N- 438N 6K0S-466G- 474G 6K0S-467K- 373K 6K0S-469J- 475K 6K0S-476G- 485G 6K0S-477J- 493J 6K0S-477K- 492K 6K0S-501F- 517F 6K0S-532F- 534F 6K0S-610L 6K0S-668L- 673L 6K0S-715R- 718R 6K0S-721R 6K0S-722R 6K0S-725R- 732R 6K0S-745N- 758N 6K0S-770R- 783R 6K0S-787R 6K0S-801K- 803K 6K0S-805K- 822K 6K0S-834N 6K0S-835N 6K0S-844G- 852G 6K0S-938Q- 946Q 6K0S-949Q- 955Q 6K0S-957Q 6K0S-958Q 6K0S-974P- 976P 6K0S-981P 6K0S-982G 6K0S-985P- 987P 6K0S-992P- 998P 7K0S100575- 579 7K0S100615- 618 7K0S100621 7K0S100714 7K0S100716 7K0S100718- 720 7K0S100936- 938 7K0S100940 7K0S101630- 634 7K0S102597- 605 7K0S102656 7K0S102657 7K0S102659- 665 7K0S102982- 986 7K0S103047- 051 7K0S103528- 532 7K0S103595- 599 7K0S103780- 784 7K0S103840- 844 7K0S103895- 899 7K0S104956- 960 7K0S105016 7K0S105020- 023 7K0S105075- 078 7K0S105080 7K0S105990- 994 7K0S106053- 056 7K0S106115 7K0S106374- 378 7K0S106397- 400 7K0S106422 7K0S106456 7K0S106458- 460 7K0S106467 7K0S107627- 631 7K0S107745- 754 7K0S107921- 925 7K0S107994- 999 7K0S108010 7K0S108012 7K0S108015 7K0S108079 7K0S108080 7K0S108255- 258 7K0S108312 7K0S108327- 330 7K0S108372- 376 7K0S108482- 486 7K0S109370- 374 7K0S109397- 401 7K0S109462- 466 7K0S109902- 906 7K0S110118- 121 7K0S110123 7K0S110136- 138 7K0S110141 7K0S110142 7K0S110412 7K0S110416- 418 7K0S110422 7K0S110427 7K0S110428 7K0S110431 7K0S110433 7K0S110434 7K0S110456 7K0S110460- 463 7K0S110484 7K0S110486 7K0S110487 7K0S110489 7K0S110492 7K0S110513 7K0S110514 7K0S110517 7K0S110518 7K0S110521 7K0S110540 7K0S110542 7K0S110543 7K0S110705 7K0S110706 7K0S110710 7K0S110711 7K0S110713 7K0S110715 7K0S110718 7K0S110732 7K0S110733 7K0S110735 7K0S110737 7K0S110739 7K0S110743 7K0S110750 7K0S110769- 771 8K0S117578- 582 8K0S125841 8K0S125842 8K0S125844- 850 8K0S125865 8K0S128089- 120 8K0S131366-399 8K0S131400- 405 8K0S131412- 416 8K0S131420- 447 9K0S134408 9K0S134500
  • 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: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX || 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