PLASTIC NEEDLE WITH MANDRIN 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 VARIAN MEDICAL SYSTEMS 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
    152416
  • 사례 위험등급
    II
  • 사례 시작날짜
    2011-07-29
  • 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
    Previous recall (53838) addressed needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal. recall 66002 supplements and modifies previous noticewhere users are instructed to stop using any plastic needles they may have in inventory with lot numbers c01 to d01 and those with lot numbers which start with h or i. this recall also requires users to return any plastic needles with lot numbers c01 to d01 and those lot numbers which start with h or i to varian brachiotherapy for replacement with plastic needles starting with lot j or higher.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: GM11007570 (Lot serial: >10 lot numbers.); Model Catalog: GM11007560 (Lot serial: >10 lot numbers.); Model Catalog: GM11007560 (Lot serial: Contact manufacturers.); Model Catalog: GM11007570 (Lot serial: Contact manufacturers.); Model Catalog: GM11007580 (Lot serial: Contact manufacturers.); Model Catalog: GM11007580 (Lot serial: >10 lot numbers.)
  • 제품 설명
    PLASTIC NEEDLE WITH MANDRIN
  • Manufacturer

Manufacturer