VACUTAINER BRAND PRESET KIT 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 BECTON DICKINSON CANADA INC. 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
    20295
  • 사례 위험등급
    III
  • 사례 시작날짜
    2016-12-29
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • 데이터 추가 비고
  • 원인
    Bd has received reports of safety cover disengagement and needlestick injury (nsi) for the bd eclipse needle. based on the customer reports in some cases when the safety cover is pushed over the needle it disengages resulting in an exposed needle which can increase the risk of nsi. some customer reports indicate an audible "click" sound before the safety cover is locked (activated) followed by a second "click" sound when the safety cover is locked over the needle. this may potentially increase the risk of nsi if the user assumes the safety cover is locked after the initial "click". bd advises customers to be aware of this matter and follow the instructions for use (ifu) to: "center your thumb or forefinger on the textured finger pad and push the safety cover forward over the needle until you hear or feel it lock. visually confirm that the needle is covered.".

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 364390 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 364391 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305786 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305785 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305784 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305783 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305782 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305781 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305780 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305779 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305778 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305768 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305767 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305766 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305765 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305764 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305763 (Lot serial: >10 NUMBERS
  • 제품 설명
    BD ECLIPSE NEEDLE (DEVICE LICENCE #788);BD ECLIPSE NEEDLE (DEVICE LICENCE #61367)
  • Manufacturer

Manufacturer