Events

Device Recall Empi STIMC RE Self Adhesive electrodes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Covidien LLC dba Uni-Patch 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
    61209
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0501-2013
  • 사례 시작날짜
    2012-02-09
  • 사례 출판 날짜
    2012-12-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-01-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107578
  • 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
    Electrode, cutaneous - Product Code GXY
  • 원인
    Covidien is conducting a voluntary recall regarding specific lots of tens electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.
  • 조치
    Covidien sent An Urgent Product Recall letter, dated February 9, 2012, to all affected consignees. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine the affected product if found. The letter asked customers to fill in teh quantity remaining in their inventory and fax it to 651-565-5888. A Covidien Customer Service rep would contact the consignee for returning product. Consignees were also requested to notify their customers of the recall. For questions regarding this recall call 508-261-8532.

Device

Device Recall Empi STIMC RE Self Adhesive electrodes
  • 모델명 / 제조번호(시리얼번호)
    Lots 200300 and 201203
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including CA, IL, MA, MN, and SD.
  • 제품 설명
    Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand || A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
  • Manufacturer
    Covidien LLC dba Uni-Patch

Manufacturer

Covidien LLC dba Uni-Patch
  • 제조사 주소
    Covidien LLC dba Uni-Patch, 1313 Grant Blvd W, Wabasha MN 55981-1058
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA