Events

Device Recall Baxter Interlink System Minivolume Extension Set 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
    34290
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0643-06
  • 사례 시작날짜
    2005-12-15
  • 사례 출판 날짜
    2006-03-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-08-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43471
  • 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, Administration, Intravascular - Product Code FPA
  • 원인
    The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
  • 조치
    Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.

Device

Device Recall Baxter Interlink System Minivolume Extension Set
  • 모델명 / 제조번호(시리얼번호)
    product code 1C8590, lot GR228668
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Australia, Japan, South Korea, Saudi Arabia, India, Mexico, Venezuela, Malaysia, East Timor and New Zealand.
  • 제품 설명
    Baxter Interlink System Minivolume Extension Set, product code 1C8590; An Rx sterile, nonpyrogenic fluid pathway, 22'', 0.9 mL Vol, with injection site and Stationary Swivel Lock T-Connector; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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