Field Safety Notice Rocket Medical Seldinger Chest Drain Kit (ICN 3149)

NHSSC: 81

Alert:

• Rocket Medical have issued a Field Safety Notice informing of an update to the Instructions for Use (IFU) (ZDOCK180) for affected Rocket Seldinger Chest Drain Kits.
• The IFU has been updated to include revised guidance regarding the need for a suture, in steps 14 and 15.

Products Affected:

• The six products affected are available from NHS Supply Chain:

Next  Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Ensure a copy of the Field Safety Notice and the updated IFU is available to all users or potential users of this device.
• Complete the Acknowledgement Form, found pages 5-7 of the notice, and return to: CustomerServices@rocketmedical.com
• Rocket Medical does not expect any disruption in the supply of these devices as a result of this notice.

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.