Events

Recall of Z Hyalin Multipack and Z Hyalin Plus MultipackZ Hyalin MultipackLot numbers: 1192BB, 1192BDARTG number: 150016Z Hyalin Plus Multipack

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Carl Zeiss Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00166-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-02-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00166-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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

Z Hyalin Multipack and Z Hyalin Plus MultipackZ Hyalin MultipackLot numbers: 1192BB, 1192BDARTG n...
  • Model / Serial
    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
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd