Field Safety Notice Rocket Medical Copeland Fetal Scalp Electrodes (ICN 2973)

NHSSC: 36

Alert:

• Rocket Medical has issued a Field Safety Notice, updating the Instructions For Use (IFU) for Rocket Copeland Fetal Scalp Electrodes.
• Revision 16 of ZDOCK167, the Instructions For Use (IFU) is missing Warning and Caution as noted on page 2 of the notice.
• These were present in previous revisions of the IFU but were erroneously removed from Revision 16.
• The missing information has now been added to Revision 17 of the IFU.

Products Affected:

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

• Please see the Field Safety Notice for more information on the products affected.
• This notice does not impact supply of the products affected.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Complete the Customer Acknowledgement Form, found on page 4 of the Field Safety Notice and return to CustomerServices@rocketmedical.com

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.