Events

Neotrode, Softrade, TruLink 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ConMed Corporation 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
    57827
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1493-2011
  • 사례 시작날짜
    2010-09-23
  • 사례 출판 날짜
    2011-03-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97513
  • 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
    ecg electrode - Product Code DRX
  • 원인
    Poor signal or loss of signal. certain recalled devices have a loose wire attachment that may lead to intermittent or poor signal quality.
  • 조치
    ConMed Corporation distributed an Urgent Device Recall notification letter on Tru-Link ECG Electrode (Neonatal Pre-wired) dated September 23, 2010. ConMed Corp. has advised to cease the use of the devices immediately and conducted a recall to the user level. Direct consignees were asked to contact sub-accounts if recalled devices were further distributed and notified them of such recall. Recalled devices were to return to ConMed Corp. at 525 French Road, Utica, NY 13502 with completed Attachment II to indicate the amount returned. Customers with no recalled devices were asked to fill out Attachment II and faxed to 315-624-3225. Questions can be directed to Ms. Patricia Cotter, ConMed Recall Coordinator at 315-624-3237 or fax to 315-624-3225 or email to neorecall@conmed.com.

Device

Neotrode, Softrade, TruLink
  • 모델명 / 제조번호(시리얼번호)
    Neotrode, Wire Attached (Catalog Number: 1731-003) Lot Code: 0904014 thru 1008134; Neotrode II, Wire Attached (Catalog Number: 1741-003) Lot Code: 0904014 thru 1008114; Softrace Limb Band (Catalog Number: 2310-003) Lot Code: 0904014 thru 1008274; Softrace Neonatal, Wire Attached (Catalog Number: 2321-003) Lot Code: 0904014 thru 1007234; Softrace Pediatric, Wire Attached (Catalog Number: 2331-003) Lot Code: 0904014 thru 1007214; and TRU-LINK ECG Electrodes (Neonatal Pre-Wired) (Catalog Number: 685-0037-00) Lot Code: 0904014 thru 1007064
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution, including USA, Dubai, Ecuador, Egypt, Germany, Holland, Indonesia, Israel, Italy, Jamaica, Kenya, Korea, Lithuania, Malaysia, Mexico, New Zealand, Norway, Qatar, Saudi Arabia, Singapore, South Africa, Sweden, Switzerland, US Virgin Islands, Canada and Belgium.
  • 제품 설명
    Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog Number: 1741-003; Softrace Neonatal Wire Attached, Catalog Number: 2321-003; Softrace Pediatric Wire Attached, Catalog Number: 2331-003; Softrace Limb Band, Catalog Number: 2310-003; TRU-LINK ECG Electrode (Neonatal Pre-Wired), Catalog Number: 685-0037-00; for use with electrocardiographic monitoring equipment to detect neonatal/pediatric heart action voltages.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • 제조사 주소
    ConMed Corporation, 525 French Road, Utica NY 13502
  • 제조사 모회사 (2017)
    CONMED Corp.
  • Source
    USFDA