Field Safety Notice Crest Medical Blue Dot Irrigation Fluid 0.9% Sodium Chloride Solution Pod 20ml MRB1140 (ICN 2476)

• The MHRA has issued Devise Safety Information (DSI) relating to Legency Remedies Private Ltd Field Safety Notice (FSN) Product Recall for sodium chloride 0.9% w/v solutions for irrigation, inhalation and eye wash.
• 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.
• Details of the Field Safety Notice and product supplied by NHS Supply Chain can be found in the below communication dated 19 March 2024.
• Full information of the DSI can be found at : 9% Sodium Chloride Solutions for Irrigation, Inhalation, and Eyewash: recall from manufacturer Legency Remedies, DSI/2024/004 – GOV.UK (www.gov.uk)

Alert:

• Crest Medical has issued a Field Safety Notice, in support of the legal manufacturer Legency Remedies Pvt Ltd, who have initiated a recall for certain batches of the Blue Dot Irrigation Fluid Pods following concerns over sterility testing.
• Please note: this notice affects only batches that have been manufactured by the legal manufacturer, Legency Remedies Pvt. Ltd

Products Affected:

• The product affected is available from NHS Supply Chain:

• Please note only the batch numbers quoted in the Field Safety Notice, page 2, are affected.
• NHS Supply Chain has quarantined any affected stock held in our depots and future orders will be fulfilled with unaffected stock.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Refer to the Field Safety Notice for images to help identify the affected products/batches.
• Cease use and quarantine all affected batches.
• Contact your local NHS supply Chain Customer Service Advisor with full details of the affected products including if the quantity is in the unit of issue or eaches.
• Your Customer Service Advisor will confirm the details and provide you with a unique CMS reference.
• Dispose of the affected products in accordance with your local regulations.
• On receipt of written confirmation, quoting your unique reference number, credit for the full value of product destroyed will be raised.

Where potential alternatives are identified, customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care Team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.