Events

Recall of Z-Hyalin Multipack

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Hyaltech 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
    14267
  • Event Initiated Date
    2013-03-04
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Carl Zeiss (NZ) Ltd, 22 Fremlin Place, Avondale, Auckland 1026
  • Reason
    Manufacturer has become aware that the sterile integrity of the pouches contained within the multipack cartons may be compromised due to an inadequate seal on the pouches.This has been observed in a small number of pouches. the sterility of the syringe contents are not affected in any way, however, the fault may affect the sterility of the outside surface of the syringe., (this recall is an extension of the hyaltechs fsn medsafe ref #13920).
  • Action
    Product to be returned to supplier

Device

Z-Hyalin Multipack
  • Model / Serial
    Model: , Affected: 1192BB, 1192BD
  • Manufacturer
    Hyaltech Ltd

Manufacturer

Hyaltech Ltd