Events

Device Recall Baxter and Baxter Interlink Buretrol Solution Sets 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
    31469
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0199-06
  • 사례 시작날짜
    2005-03-17
  • 사례 출판 날짜
    2005-11-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-03-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37950
  • 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 buretrol solution sets are currently labeled as acceptable for use with the colleague volumertric pump, but there is a potential for a non-detection of an upstream occlusion under certain conditions.
  • 조치
    Urgent Device Correction letters dated 3/17/05 were sent to the direct accounts via first class mail on 3/17/05, to the attention of the director of nursing. The letters informed the accounts that there is a potential for a non-detection of an upstream occlusion under certain conditions if the product codes 2C7546(S) and 2C7566(S) Buretrol Solution Sets are used with the Colleague Infusion Pumps. Baxter recommends that these product codes no longer be used with the Colleague pumps, and listed product codes 2C7519(S) and 2C7564(S) as alternative compatible sets that can be used with the Colleague pumps. Any questions concerning the compatibility of other Buretrol sets with the Colleague pumps were directed to Baxter Medication Delivery Product Information Center at 1-800-933-0303. Since teh two product codes are no longer recommended for COlleague pumps, the accounts were given the choice of returning their stocks of the two product codes for credit and order an alternative by calling Baxter Healthcare Center for Service at 1-888-229-0001. Questions regarding the communication were directed to the Center for One Baxter at 1-800-422-9837.

Device

Device Recall Baxter and Baxter Interlink Buretrol Solution Sets
  • 모델명 / 제조번호(시리얼번호)
    all lots of product codes 2C7546(S) and 2C7566(S), as well as A2C7572, A2C9568 and A2C9584 for the Australian market, JC7566 for the Canadian market, and VMC9602P for the European market.
  • 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 Japan, Mexico, Australia, New Zealand, Hong Kong, Singapore, Switzerland, China, Uruguay, East Timor, Armenia and Panama.
  • 제품 설명
    Buretrol Solution Sets, a sterile fluid pathway of various lengths, 60 drops/mL, with 150 mL Burette Ball Valve, 2 injection sites and male luer lock adapter; 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