Field Safety Notice Argon Medical Biopsy Instruments Multiple Products (ICN 2600)
Important Customer Notice Field Safety Notice
- Argon Medical has issued a Field Safety Corrective Action Notice following complaints of holes in the sterile barrier of the tray packaging for a range of products.
- As of 17 July 2024, Argon Medical has advised unaffected stock is now available to order through our online catalogue.
MHRA TBC
NHS Supply Chain Reference : 29
Alert:
- Argon Medical has issued a Field Safety Corrective Action Notice following complaints of holes in the sterile barrier of the tray packaging for a range of products.
- Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the access site, leading to an infectious process, bacteraemia or sepsis. There is no risk to the user, only the patient.
- Argon Medical advise on receipt of the product complaint they immediately initiated an investigation and have determined the root cause and are taking corrective action.
Products Affected:
- The products affected are available on NHS Supply Chain’s eDirect Route. Please refer to the attached product listing for full details.
- Please note only the lot numbers quoted in the Field Safety Corrective Action Notice are affected.
- Argon Medical advise there will be an approximate two week delay in supply of unaffected products.
Next Steps:
- Read and follow the full instructions in the Field Safety Corrective Action Notice and share with all users of the affected products.
- Cease use and quarantine all affected products.
- Complete the Customer Response Form, page 4 of the Field Safety Corrective Action Notice and email to: uksales@argonmedical.com as soon as possible.
- On receipt Argon Medical will contact you to arrange collection of all affected products.
- Contact your NHS Supply Chain Customer Service Advisor with details of all products found and collected to enable us to raise your Customer Credit.
Please Note:
- Argon Medical advise they have emailed a customer specific Field Safety Corrective Action Notice to all affected customers detailing the affected products and lot numbers supplied.
- NHS Supply Chain is issuing this Important Customer Notice in support of this action and to request when returning affected products to Argon you also contact your NHS Supply Chain Customer Service Advisor with full details to enable us to raise your 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.