Product Recall Rocket Medical Thoracentesis Catheters R51551-08-00 and Thoracentesis Catheter R51551 (ICN 2737)

MHRA TBC

NHSSC Ref: 72

Alert:

• Rocket Medical has issued a Field Safety Notice having identified a manufacturing issue affecting specific Lot numbers for two Chest Drainage Devices.
• The adhesive glue used to secure the drainage line to the stitch plate was not correctly applied.
• As a result, the drainage line may separate from the tap.
• Some users may have resorted to using adhesive tape to secure the connection. Using tape to secure the drainage line is not an acceptable fix and should not be performed.

Products Affected:

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

• Please note only the Lot numbers quoted in Table 1, page 2 of the Field Safety Notice are affected.
• NHS Supply Chain warehouses have been checked and future supplies of these products will be of different, unaffected Lot numbers.
• Rocket Medical advise this recall 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 devices.
• Quarantine and do not use any of the affected devices.

Return Instructions:

• Rocket Medical will replace any of the Lot numbers listed in Table 1 of the Field Safety Notice directly with customers.
• Complete the Rocket Medical Replacement Form and the Device Collection Information, pages 5 and 6 of the Field Safety Notice, and return to: fieldsafetynotices@rocketmedical.com.
• On receipt of the completed forms Rocket Medical will arrange for free of charge replacements to be issued.

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.