Ellex Medical Pty Ltd. 2023-07-05 Health serious FDA
Health · FDA · Recall #FDA-Z-1971-2023
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre… Recall
Issued July 5, 2023 · Ellex Medical Pty Ltd.
In July 2023, Ellex Medical Pty Ltd. recalled the Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired.
What you should do
- 1 Stop using Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Ellex Medical Pty Ltd. to arrange your fda mandated. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (FDA Mandated):
Recall details
- Brand
- Ellex Medical Pty Ltd.
- Category
- Health
- Recall date
- July 5, 2023
- Units affected
- Not reported
- Sold at
- US nationwide/ Worldwide Distribution
- Recall number
- FDA-Z-1971-2023
- Made in
- Australia
- Issuing agency
- FDA
In context
- Ellex Medical Pty Ltd. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.