Device Recall Monoject Insulin Safety Syringe 1/2mL 29 X 1/2" 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Covidien LLC 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
    61908
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1696-2012
  • 사례 시작날짜
    2012-05-21
  • 사례 출판 날짜
    2012-05-31
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-06-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Syringe, piston - Product Code FMF
  • 원인
    Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick.
  • 조치
    Covidien sent an Urgent Product Recall letter dated May 21, 2012, via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using any affected product. Distributors were requested to notify their customers. Customers were instructed to complete the Monoject Insulin Safety Syringe recalled product return form even if they have no product to return. The form should be faxed to 1-800-895-6140 or e-mailed to sdfeedback@covidien.com. Customer Service questions regarding the recall please use one of the following methods. Telephone:1-800-722-8772 option I (Weekdays, 8am to 6:30pm Eastern) e-mail:sdfeedback@covidien.com

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Code: Any lot in the series 015806-033106
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Belgium, and Panama.
  • 제품 설명
    Monoject Insulin Safety Syringe 1/2mL 29 X 1/2" || Product ID: 8881511136 || Indications for Use: Injection of U-1 00 insulin
  • Manufacturer

Manufacturer

  • 제조사 주소
    Covidien LLC, 15 Hampshire Street, Mansfield MA 02048-1113
  • 제조사 모회사 (2017)
  • 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