Z Hyalin Multipack and Z Hyalin Plus MultipackZ Hyalin MultipackLot numbers: 1192BB, 1192BDARTG number: 150016Z Hyalin Plus Multipack 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Carl Zeiss 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-2013-RN-00166-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-02-22
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    The manufacturer has determined a potential issue relating to the sterile integrity of the pouches contained in the z hyalin multipack and z hyalin plus multipack. the content of the syringe has not been compromised, however the seal of the pouch for each individual syringe may not be adequate and sterility of the outer surface of the syringe could be compromised.This recall action was undertaken prior to notification to the tga.
  • 조치
    Affected batches should be identified and immediately returned to Carl Zeiss Pty Ltd. All lot numbers should be examined for package inegrity prior to use, as stated in the instructions for use.

Device

  • 모델명 / 제조번호(시리얼번호)
    Z Hyalin Multipack and Z Hyalin Plus MultipackZ Hyalin MultipackLot numbers: 1192BB, 1192BDARTG number: 150016Z Hyalin Plus MultipackLot numbers: 2218AA, 2218AB. 2228AA, 2194AA, 2192APARTG number: 150017
  • Manufacturer

Manufacturer