Field Safety Notice Rocialle Healthcare Procedure Packs (ICN 2284)

Alert:

• Rocialle Healthcare has issued a Field Safety Notice recalling all Lot numbers of their procedure packs containing a medium vinyl examination glove which does not meet break test standards.
• Rocialle Healthcare advises glove breakage is unlikely to lead to user or patient injury with a serious adverse event, it presents a minor risk.
• Rocialle Healthcare reports they have received no customer complaints or feedback as a result of glove breakage.

Products Affected:

• One of the three product codes affected is available from the NHS Supply Chain’s Blue Diamond Route.

• Please note products marked RML101-007-REVB are NOT affected.
• Rocialle Healthcare advise all future issues of the product code EGJ237 will be of RML101-REVB and are available now.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share them with all users of the affected products.
• Cease use and quarantine all affected batches.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of affected products including NPC, Lot numbers and quantity stating whether boxes or eaches.
• Your Customer Service Advisor will give you a unique CMS log number on receipt of written confirmation and will raise the appropriate credit.
• This must be in the form of an email, quoting the CMS reference and confirming the disposal is in accordance with your local regulations.
• 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 or Product Recall, we may need to provide manufacturers, UK responsible Persons and Distributors 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.