Events

Device Recall Safe Connect 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Remington Medical 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
    55804
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2223-2010
  • 사례 시작날짜
    2010-05-19
  • 사례 출판 날짜
    2010-08-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-11-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91851
  • 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
    Cable, transducer and electrode, patient (including connector) - Product Code DSA
  • 원인
    The safe connect component may separate from the cable, causing the cable to become unplugged from the epg.
  • 조치
    Consignees were notified on/about 05/19/2010. They were instructed to examine their inventory and quarantine product subject to the recall. If they distributed the product, they were advised to identify their customers and notify them of the recall (via the recall letter). A Return Authorization was provided. More information can be obtained by calling 770.888.8520.

Device

Device Recall Safe Connect
  • 모델명 / 제조번호(시리얼번호)
    Lot number: 100701
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AZ, CA, CO, CT, DE, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NM, NY, OH, OK, OR, PA, SC, TX, TN, TX, VA, WA, WI and Canada.
  • 제품 설명
    Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005 || Usage: Temporary pacing of open hearts: used with External Pacing Generators (EPGs).
  • Manufacturer
    Remington Medical Inc.

Manufacturer

Remington Medical Inc.
  • 제조사 주소
    Remington Medical Inc., 6830 Meadowridge Ct., Alpharetta GA 30005
  • 제조사 모회사 (2017)
    Remington Medical, Inc.
  • Source
    USFDA