Events

Dimetapp Saline Nasal Drops for Infants 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Pfizer Australia Pty Ltd 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
    RC-2014-RN-01036-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-10-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01036-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Pfizer is recalling dimetapp saline nasal drops for infants following a complaint received by tga. the nature of the complaint involved the nozzle of the product becoming dislodged and subsequent flowing of the saline fluid onto a baby’s face.
  • 조치
    Retailers and wholesalers are requested to inspect their stock and quarantine all units from the affected batches (21320 and 21465). Retailers are also requested to retain any units returned by consumers and provide a refund or replacement. This action has been closed-out on 18/07/2016.

Device

Dimetapp Saline Nasal Drops for Infants
  • 모델명 / 제조번호(시리얼번호)
    Dimetapp Saline Nasal Drops for InfantsBatch numbers: 21320 & 21465ARTG Number: 167019
  • Manufacturer
    Pfizer Australia Pty Ltd

Manufacturer

Pfizer Australia Pty Ltd
  • 제조사 모회사 (2017)
    Pfizer
  • Source
    DHTGA