Events

Pine O Cleen DisinfectantHospital Grade 1.25 Plastic Bottles 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Reckitt Benckiser 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-2018-RN-00207-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-03-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00207-1
  • 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
    Pine o cleen disinfectant hospital grade (artg: 60110) in 1.25l plastic bottles may have a sub visible stress crack in the bottle neck which may cause the bottle to leak or the cap to break off at the neck and spillage may occur. in the event this happens it will typically occur when the bottle is opened for the first time or within the first few uses.The health risk associated with this issue is accidental exposure to skin and eyes potentially causing transient irritation that would likely be self limiting.If there is contact with the eyes or skin, wash the area with a large amount of water. if irritation persists see your doctor.This recall does not affect any other batches or sizes of pine o cleen disinfectant or any other rb products. this batch has been distributed to retail trade from january 16th 2018 until february 24th, 2018.All product received post february 24th, 2018 is not affected.
  • 조치
    Customers are asked to inspect their stock on hand and return affected product as per the instructions given in the Customer Letter

Device

Pine O Cleen DisinfectantHospital Grade 1.25 Plastic Bottles
  • 모델명 / 제조번호(시리얼번호)
    Pine O Cleen DisinfectantHospital Grade 1.25 Plastic BottlesARTG Number: 60110(RECKITT BENCKISER NON-STERILE DISINFECTANTS, WITHOUT CLAIMS 'BENZALKONIUM CHLORIDE')
  • Manufacturer
    Reckitt Benckiser Pty Ltd

Manufacturer

Reckitt Benckiser Pty Ltd