Events

Device Recall PowerLoc MAX Safety Winged Infusion Set 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bard Access Systems 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
    70834
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1560-2015
  • 사례 시작날짜
    2015-03-13
  • 사례 출판 날짜
    2015-04-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135029
  • 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
    Bard access systems is conducting a field action due to the potential that an incorrect maximum flow rate label associated to the power injection ifu for the powerloc max safety infusion set (swis) was attached to the outside of the unit pouch.
  • 조치
    The firm, Bard, sent an "URGENT: Notification-Potential Incorrect Infusion IFU Label for PowerLoc¿ MAX Safety Winged Infusion Set (SWIS)" letter dated March 25, 2015 to its customers. The letter described the product, problem and actions taken. The firm has corrected the cause of the issue and all future lots will be manufactured with the correct maximum flow rate of 2mL/second. Customers may return for a replacement or keep items. Please direct any return requests and questions to our coordinator at 801-522-5640.

Device

Device Recall PowerLoc MAX Safety Winged Infusion Set
  • 모델명 / 제조번호(시리얼번호)
    Lot D430107
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to states of: GA and MN.
  • 제품 설명
    PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 || The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The PowerLoc MAX SWIS is also indicated for power injection of contrast media into the central venous system only with an implanted port that is also indicated for power injection.
  • Manufacturer
    Bard Access Systems

Manufacturer

Bard Access Systems
  • 제조사 주소
    Bard Access Systems, 605 North 5600 West, Salt Lake City UT 84116-3738
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA