Events

dolphin Inflation Device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Vascular Solutions, Inc. 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
    77095
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2180-2017
  • 사례 시작날짜
    2017-04-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-04-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154966
  • 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
    Syringe, balloon inflation - Product Code MAV
  • 원인
    The manufacturer of the dolphin inflation device, perouse medical, has initiated a recall of the device due to a potential defect in the sterile barrier. use of affected product could pose a risk of microbial contamination, leading to infection.
  • 조치
    Customers were sent a Vascular Solutions "Urgent Medical Device Removal letter" dated April 12, 2017. The letter described the problem and the product involved in the recall. Advised consignees to remove and secure all affected product and to complete and return the "VSI Account Inventory Form". For questions contact your local Vascular Solutions Sales Representative. For further questions, please call (763) 656-4300.

Device

dolphin Inflation Device
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 15075668, 15075924, 15115426, 15125175, 16025324, 16035493, 16055261.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution including PR and to the states of : LA, TN, CA, SC, OR, WA, OK, NV, HI, OH, TX.
  • 제품 설명
    Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. || DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc). || The manually operation of the DOLPHIN is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device. || Instantaneous deflation, regardless of balloon size, is made possible by the release of the dual locks located on device as well as a large, 30 cc syringe that is sold with each Dolphin Inflation Device. || All the while during inflation or deflation pressure is displayed and can be monitored on a large analog gauge mounted on top of the device.
  • Manufacturer
    Vascular Solutions, Inc.

Manufacturer

Vascular Solutions, Inc.
  • 제조사 주소
    Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA