Events

Device Recall FASLOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. 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
    67752
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1441-2014
  • 사례 시작날짜
    2014-03-05
  • 사례 출판 날짜
    2014-04-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-04-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126209
  • 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
    Remington medical discovered an error on the fl-601-97 ifu; part number ifu-rm-0154. specifically, the polarity for the black chuck in the picture is wrong. it shows (+), but should show (-).
  • 조치
    Remington Medical Inc sent an Field Safety Notice dated March 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please be aware that the typographical error described above is included in the FL-601-97 Instructions for Use (RM-0154 Rev 05) provided with the lots that you have received as identified below. RMI has corrected the typographical error in the revised FL-601-97 Instructions for Use (RM-0154 Rev 5.1) which is attached to this communication. Please incorporate the information contained in the attachment with the existing FL-601-97 labeling (Instructions for Use) provided with the product. If you have distributed these products further, please forward copies of this notice and the revised Instructions for Use to any recipients as appropriate. If you have any questions regarding this communication, please contact RMIs sales representatives or customer service team at 800-989-0057, Monday - Friday, between the hours of 8 am - 4pm EST. Patient safety is the highest priority for Remington Medical, Inc. We appreciate your assistance with this matter and regret any inconvenience this may cause.

Device

Device Recall FASLOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down.
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 131901, 132262, 132263, 132533, 132693, 132694, 132833 132835, 132986, and 133171.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) Distribution including Canada
  • 제품 설명
    FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. || Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The cable is a sterile, disposable device.
  • Manufacturer
    Remington Medical Inc.

Manufacturer

Remington Medical Inc.
  • 제조사 주소
    Remington Medical Inc., 6830 Meadowridge Ct, Alpharetta GA 30005-2202
  • Source
    USFDA