Product Recall Johnson & Johnson MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrode FDJ3091 (ICN 2548)

Alert:

• Megadyne Medical Products Inc. has initiated a voluntary medical device recall (removal) of all distributed Lots of the MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrode.
• Megadyne has received reports of patient burn injuries in procedures where the Mega Soft Patient Return Electrodes were used, up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries.
• Megadyne has decided to discontinue and recall all Pediatric Patient Return Electrode FDJ3091 (MPC 0840).

Products Affected:

• The affected product is available from NHS Supply Chain:

• This product will be suspended and is no longer available to order.

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 affected products.
• Complete the Business Reply Form, found page 4 of the notice, and return to MDFieldActionsUKIrl@its.jnj.com to arrange collection of affected products.
• Please also contact your NHS Supply Chain Customer Service Advisor with full details, including quantities and Lot numbers you are returning to the supplier to enable us to manage your credit where appropriate.

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.