Events

Device Recall Triton Administration Sets 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 WalkMed Infusion, LLC 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
    74437
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2233-2016
  • 사례 시작날짜
    2016-06-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147552
  • 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
    Walkmed infusion, llc announces a voluntary field action of multiple triton administration sets due to the potential presence of particulate in or on the administration sets.
  • 조치
    Terumo sent a notification letter dated June 8, 2016 to customers. The letter identified the affected product, problem and action to be taken. Customers were instructed to 1. Review this notice and ensure that all users receive notice of this issue. 2. Return the attached Customer Response Form acknowledging receipt of this notice. 3. Source a replacement for the Interchlor sanitizer. See information above or call Terumo CVS Technical Support for assistance. 4. Terumo CVS will provide users with updated user instructions regarding the 10% Sodium Hypochlorite sanitization solution. Instructions will be provided under separate cover, when available. For questions contact your Terumo representative or contact Terumo CVS Technical Support at 800.441.3220, extension 6932.

Device

Device Recall Triton Administration Sets
  • 모델명 / 제조번호(시리얼번호)
    Product Number: 020-300650. Lot Number: 1412070D, 1502055D, 1503039D, 1505047D, 1506051D, 1506052D
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.
  • 제품 설명
    T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. || Product Usage: || Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
  • Manufacturer
    WalkMed Infusion, LLC

Manufacturer

WalkMed Infusion, LLC
  • 제조사 주소
    WalkMed Infusion, LLC, 6555 S Kenton St Ste 304, Englewood CO 80111-6838
  • 제조사 모회사 (2017)
    Walkmed Infusion LLC
  • Source
    USFDA