Events

Recall of Eyesaline Eyewash Solution, 32oz, for use with Eyesaline Wall Station (for emergency eye rinsing)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Honeywell Safety Products.

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-2016-RN-01226-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01226-1
  • 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
    Honeywell is recalling a single lot of 32oz eyesaline eyewash solution because of reports of possible contamination with klebsiella pneumoniae. there could be an increased health risk of eye infections, and infections for individuals with cuts, scrapes, rashes or other compromised skin conditions; or those with weakened or suppressed immune systems. there have been no reports of injury.
  • Action
    Consumers are being contacted by retailers who have been supplied with the product by Honeywell. This action has been closed-out on 09/06/2017

Device

Eyesaline Eyewash Solution, 32oz, for use with Eyesaline Wall Station (for emergency eye rinsing)
  • Model / Serial
    Eyesaline Eyewash Solution, 32oz, for use with Eyesaline Wall Station (for emergency eye rinsing)Lot Number: F16091-61
  • Manufacturer
    Honeywell Safety Products

Manufacturer

Honeywell Safety Products