Device safety informationMHRA
0.9% Sodium Chloride Solutions for Irrigation, Inhalation, and Eyewash safety warning over a safety concern
Batches of Legency Remedies Pvt Ltd irrigation, inhalation and eye wash saline products manufactured between April and November 2023 are being recalled due to potential microbiological contamination.
What to do now
0.9% Sodium Chloride Solutions for Irrigation, Inhalation, and Eyewash is the subject of an MHRA device safety notice.
- Speak to the clinic, hospital or supplier who gave you the device before changing how you use it.
- Check the model, lot or serial number against the details on this page.
- Any incident involving the device can be reported through the Yellow Card scheme.
Why it matters. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
Replacements and support
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next.
Do not throw away a device you rely on until a replacement has been arranged.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2024/004). Quoted as issued.
Summary
Batches of Legency Remedies Pvt Ltd irrigation, inhalation and eye wash saline products manufactured between April and November 2023 are being recalled due to potential microbiological contamination.
The risk
Devices Details Device Name Sodium Chloride Irrigation Solution 0.9% w/v, Sodium Chloride Eye Wash Solution 0.9% w/v and Sodium Chloride Inhalation Solution 0.9% w/v
Advice for healthcare professionals
Actions for healthcare professionals and providers
Review your inventory of 0.9% sodium chloride solutions intended for irrigation, inhalation and eyewash, and determine if any of the batch numbers listed in the FSN are present in your stock.
Check any clinical equipment packs or first aid kits that might contain any of the 0.9% sodium chloride solutions listed in the FSN and determine if any of the batch numbers listed in the FSN are present in these packs.
Immediately stop use, quarantine and stop supply of any identified product(s).
Where possible, contact any customers who have received or may have received the affected product(s) and ask them not to use the product(s) and to return them to the original place of purchase.
Follow the actions set out in the FSN .
There are specific reporting arrangements for healthcare professionals to follow in each region. Healthcare professionals should report incidents:
in England and Wales to the Yellow Card scheme or via the Yellow Card app
in Scotland to Incident Reporting & Investigation Centre (IRIC) and their local incident recording system
in Northern Ireland to the Northern Ireland Adverse Incident Centre and their local incident recording system
Alternative sodium chloride 0.9% solution products are readily available for use in irrigation, inhalation and eye wash. Suppliers of these products have been contacted and have confirmed there is adequate supply in the market to support the recall of affected Legency batches.
Actions for patients/customers
Open the MHRA notice
Questions
Why has 0.9% Sodium Chloride Solutions for Irrigation, Inhalation, and Eyewash been recalled?
0.9% Sodium Chloride Solutions for Irrigation, Inhalation, and Eyewash is the subject of an MHRA device safety notice. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
Speak to the clinic, hospital or supplier who gave you the device before changing how you use it. Check the model, lot or serial number against the details on this page.
Who replaces the device?
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next. Do not throw away a device you rely on until a replacement has been arranged.