Events

Device Recall Fenwal 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Corp. 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
    26772
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1175-03
  • 사례 시작날짜
    2003-07-16
  • 사례 출판 날짜
    2003-08-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-06-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28422
  • 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
    Set, Blood Transfusion - Product Code BRZ
  • 원인
    There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
  • 조치
    Recalled by letter dated 7/16/03. The accounts were informed of the potential for leaks in the set tubing, and asked to inspect their inventory for the affected product codes and lots, segregate any affected products found and discard them according to local procedures. The customers will receive credit for the discarded affected product.

Device

Device Recall Fenwal
  • 모델명 / 제조번호(시리얼번호)
    catalog 4C6766, lot numbers UR140772 through UR166058. Please note: Baxter lot numbers are represented by an internal reference code ''UR'' followed by a six digit sequential number, or by the letter ''U'' followed by a six digit sequential number with and ''R'' suffix. Any lot number appearing within the identified six digit sequential number range is subject to the recall.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Mexico, Canada, Columbia, Australia, New Zealand and Taiwan
  • 제품 설명
    Fenwal Straight Type Blood Set with Large Standard Blood filter, 15 drops/mL, 80'', 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 4C6766; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • 제조사 주소
    Baxter Healthcare Corp., Rt 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA