Events

Device Recall EndoVive 3s Low Profile Balloon Kits 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Xeridiem Mediem Medical Devices 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
    73024
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0935-2016
  • 사례 시작날짜
    2015-12-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142799
  • 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
    Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
  • 원인
    A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
  • 조치
    Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customer was provided the following instructions: 1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users. 2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users. For any questions the customers is instructed to contact the firm. For questions regarding this recall call 520-882-7794.

Device

Device Recall EndoVive 3s Low Profile Balloon Kits
  • 모델명 / 제조번호(시리얼번호)
    Part Number: M00548530 (XMD P/N 70-0050-416)  Lot Number: 911111 915911 920211 919005 920611 928916 930826
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution to MA only.
  • 제품 설명
    EndoVive 3s Low Profile Balloon Kits || Part Number: || M00548530 || (XMD P/N 70-0050-416) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
  • Manufacturer
    Xeridiem Mediem Medical Devices Inc

Manufacturer

Xeridiem Mediem Medical Devices Inc
  • 제조사 주소
    Xeridiem Mediem Medical Devices Inc, 4700 S Overland Dr, Tucson AZ 85714-3430
  • Source
    USFDA