Device Recall BD Interlink threaded lock cannula 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton Dickinson & Company 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
    67098
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0772-2014
  • 사례 시작날짜
    2013-11-26
  • 사례 출판 날짜
    2014-01-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-05-06
  • 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
    Cannula, injection - Product Code FGY
  • 원인
    Bd interlink threaded lock cannula ref# 303369 and lot #3021392 is being recalled due to the potential that a small percentage of the lot may exhibit open seals which adversely impacts unit package integrity and product sterility.
  • 조치
    BD Diagnostics sent an Urgent: Voluntary Product Recall letters/Notice of Return dated November 26, 2013, to all affected customers. Customers were asked to identify and segregate stock of the affected number, inform the appropriate personnel in their organization to discontinue use of the affected product, return the afected product, following the instructions on the enclosed packing slip, BD would issue a credit for product returned. If product was further distributed customers were instructed to identify their customers and notify them at once of the product recall using the provided customer communication. Customers were asked to complete the attached notice and fax to 855-731-0157. Customers with questions were instructed to call 1-855-731-0157. For questions regarding this recall call 755-731-0157.

Device

  • 모델명 / 제조번호(시리얼번호)
    Marketing Status: Class II, 510K # K011858 Device Listing Number: D043644  Lot number 3021392
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Canada and Japan.
  • 제품 설명
    BD Interlink threaded lock cannula || This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ injection site. It is screwed down over the Interlink¿ injection site and a blunt plastic cannula inside the housing enters the Interlink¿ injection site to provide a pathway for IV fluid administration.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • 제조사 모회사 (2017)
  • Source
    USFDA