Field Safety Notice Flexicare BriteBlade Product Recall (ICN 2183)

Alert:

• The supplier Flexicare has issued a Field Safety Notice affecting the BriteBlade Pro Single-use Flexible McCoy Type Blade Size 4 due to the potential that the blade is not sterile as indicated on the product packaging.
• Laryngoscope blades are not commonly provided as sterile and therefore Flexicare believe the risk to patients who have or will receive treatment using this device is low.

Products Affected:

•  The product affected is available on NHS Supply Chain’s eDirect service:

• Please note only the lot numbers listed in the Field Safety Notice are affected. This withdrawal should have no impact on future supplies.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Check your inventory and quarantine all devices found with the lot numbers listed. The lot number can be found on both the outer box label and the individual packaging.
• Complete the Field Safety Acknowledgment Form, page three of the Field Safety Notice, and email it to Flexicare Medical Limited: Quality@flexicare.com to arrange return for credit or replacement of these devices.
• Contact your local NHS supply Chain Customer Service Advisor with full details of the affected products to return to Flexicare, to enable us to assist, including raising customer credit where appropriate.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or Customer Relationship Manager.

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.