Events

Argyle" Suction Tubing 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Minimally Invasive Therapies Group 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
    79352
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0936-2018
  • 사례 시작날짜
    2017-10-24
  • 사례 출판 날짜
    2018-03-05
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162107
  • 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
    Tubing, noninvasive - Product Code GAZ
  • 원인
    Incorrect packaging. in one lot of argyle suction tubing, the pouch may be incorrectly labeled as the salem sump dual lumen stomach tube. this product may have been distributed within the case of argyle suction tubing.
  • 조치
    An URGENT MEDICAL DEVICE RECALL letter was issued to customers on October 24, 2017. This letter notified customers of the products subject to the recall and stated the following: The primary package labeling (Label closest to the product) may be incorrect. Customers can identify the affected product by consulting Attachment B. Please quarantine and return any unused products of the item codes and lot detailed above. Unused products from the affected item code and lots should be returned as described in the Required Actions section below. If you have distributed the Argyle" Suction tubing listed above, please promptly forward the information from this letter to those recipients. All unused products from the affected item codes and lots must be returned. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.

Device

Argyle" Suction Tubing
  • 모델명 / 제조번호(시리얼번호)
    710016864X
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) Distribution
  • 제품 설명
    Argyle Suction Tubing (Product # 8888301515) || Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room, bonded with 2 female sure grip connectors at each end of the tube to facilitate the plug/ insertion of the device and also includes a male connector that can be used for devices designed with female connectors, This product is sterile, non-conductive and latex free.
  • Manufacturer
    Medtronic Minimally Invasive Therapies Group

Manufacturer

Medtronic Minimally Invasive Therapies Group
  • 제조사 주소
    Medtronic Minimally Invasive Therapies Group, 15 Hampshire St, Mansfield MA 02048-1113
  • 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