Field Safety Notice Farla Medical Sterility Issues Across Various Products (ICN 2980)

NHSSC: 03

Alert:

• Farla Medical has issued a Field Safety Notice due to the sterility and performance of affected products not being assured.
• The supplier has been made aware that the subcontractor may not have adhered to the required regulatory oversight, resulting in potential non-compliance with the essential safety and performance standards outlined under UK Medical Device Regulations.
• While no immediate adverse events or customer complaints have been reported to the supplier, the deviation from regulatory requirements means that the quality and performance of these products cannot be fully guaranteed.

Products Affected:

• There are ten NHS Supply Chain product codes affected. Please see the attached product listing for more information.
• Please note only the batch numbers quoted in the advisory letter are affected.
• The affected lots were supplied to NHS Supply Chain throughout 2021 to early 2023.
• Please note that some product codes are delisted are no longer available to order.
• There are also instances of the same product having multiple product codes due to the differences in pack sizes.
• Other product codes for the impacted products are available to order through our online catalogue. These product codes were set up after the affected lots were distributed and/ or Farla Medical have confirmed that NHS Supply Chain has not transacted the affected lot and are not impacted by this notice.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all the affected lot numbers.
• Complete the attached Customer Response Form and return to recall@farla.co.uk
• Contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including product codes, lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number.
• Dispose of the affected products in accordance with your local regulations. Upon written confirmation of disposal in the form of an email, quoting the CMS reference, your Customer Services Advisor will raise the appropriate credit.

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.