Field Safety Notice Rocket Medical Chest and Abdominal Drain Set (ICN 3279)
Important Customer Notice Status New Type Product Alert
NHSSC: 118
Alert:
- Rocket Medical has issued a Field Safety Notice CUST-OCC665 Revision 2 dated 6 March 2026. This updates their Field Safety Notice GB-MF-000025375, released in November 2023.
- The 2023 notice was not received by NHS Supply Chain.
- The revision has been issued to ensure all users who potentially hold in-date product are aware of a potential issue with one lot number where during manufacture the needle of the blue drain device may have punctured the catheter wall.
- This fault renders the product useless and poses a risk of needle stick injury to the user.
Products Affected:
- One product is affected.
- The affected product is available via NHS Supply Chain:
|
NPC |
Product Description | Supplier Code / MPC | Affected Lot Number |
Route |
|
FSW486 |
Chest and abdominal needle drain set Multipurpose Blue Drain for Pleural and abdominal drainage | R58800-06-BD | 499948 | Stocked |
- Please note only the lot number quoted in the Field Safety Notice is affected.
- All NHS Supply Chain stock has been checked with no affected products found.
- Future orders will be fulfilled with unaffected stock.
- Rocket Medical advise this issue has no impact on the availability or supply of this product.
Next Steps:
- Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
- Check your inventory for the affected lot number.
- Carefully examine the product, if the needle can be seen protruding through the wall of the catheter, see figure 2, page 2 of the Field Safety Notice, the product should be discarded immediately without being used.
- Dispose of the damaged product in accordance with your local regulations.
- Complete the FSN Acknowledgment Form, page 4 of the Field Safety Notice, whether you have affected products or not and return to: CustomerServices@rocketmedical.com
- Where damaged products are found, and destroyed, please also contact your local NHS Supply Chain Customer Service Adviser with the full details to enable us to record the details and raise the appropriate credit.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute 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.
