Field Safety Notice Kimal Namic White Star Handle Manifolds and Namic Rotating Adaptor Syringes (ICN 3326)

• NHS England has also issued a communication dated 23 April 2026, publication reference: PRN02516.
• See our Downloads ▼ section to view the NHS England letter.

NHSSC: 3

MHRA :

2026/004/017/601/053 – Namic White Star Handle Manifolds

2026/004/017/601/048 – Rotating Adaptor Syringes

DSI/2026/002

Update:

• Kimal has issued a customer update, dated 20 May 2026, regarding the ongoing Field Safety Notice (FSN) affecting Namic Manifolds, including Kimal procedure packs containing manifolds, and the subsequent Device Safety Alert issued by the MHRA on 19 May 2026 – DSI/2026/002.
• Kimal Procedure Packs – MHRA-Approved Warning Labelling
  • The supplier is currently working through the labelling process and will be shipping specific packs to customers as swiftly as possible.
• Option to Receive a Sterile Replacement Manifold
  • Kimal has been working with both Medline and other manifold suppliers to be able to supply a separately packaged sterile manifold to accompany your procedure packs.
  • It is anticipated this option will be available shortly, however the supplier is not in a position to confirm a date.
• Please advise your Kimal Sales Representative whether you do or do not wish to receive a separately packaged sterile manifold alongside your procedure packs.
• Please see our Downloads section to review the customer letter.

NHSSC: 3

MHRA:

2026/004/017/601/053 – Namic White Star Handle Manifolds

2026/004/017/601/048 – Rotating Adaptor Syringes

DSI/2026/002

Update:

• MHRA has issued a Device Safety Information (DSI) regarding Medline Industries LP and Kimal PLC having identified safety issues with the Namic Angiographic Control Syringes with RA and Namic White Star Off Handle Manifold devices. See our Useful Links section to view the MHRA’s DSI on the Gov.uk website.
• In support to the instructions found in the suppliers’ Field Safety Notices (found in our download section), the DSI advises customers:
  • Identify whether your site uses Kimal procedure packs containing the Namic RA syringes and/or Namic Manifolds primarily for diagnostic or interventional cardiology or radiology procedures.
  • Check your stock and identify any affected products.
  • As outlined in the updated Kimal Syringe FSN 2026/004/017/601/048 and Kimal Manifold FSN 2026/004/017/601/053, apply the provided over-labels to the identified procedure packs. Customers must follow the instructions within the FSNs to obtain the labels from the manufacturer. The labels state that affected syringes and manifolds must be removed and discarded from further use.
  • Remove and destroy all affected products unless there is no alternative and the use is unavoidable.
  • In emergency situations, where the use of the Namic RA syringe and Namic manifold is required for a specific procedure, where there are no alternative devices available, and delaying the procedure would place the patient at significantly increased risk, the use of these devices may be considered as a last resort.
  • Ensure systems are in place for healthcare professionals to undertake the following actions
• Please review and follow all instructions found within the Device Safety Information.
• For products purchased via NHS Supply Chain that are to be destroyed, please also contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including product code, lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number.
• Dispose of the affected products in accordance with your local regulations. Upon written confirmation of disposal in the form of an email, quoting the CMS reference, your Customer Service Advisor will raise the appropriate credit.

NHSSC: 3

MHRA : 2026/004/017/601/053 – Namic White Star Handle Manifolds
2026/004/017/601/048 – Rotating Adaptor Syringes

Update:

• Kimal has issued a customer update, dated 6 May 2026, regarding Namic Manifolds, including Kimal procedure packs that contain these manifolds.
• The customer update provides customers with information on:
  • Updated Warning Labels on Kimal Procedure Packs
  • Option to receive a separate sterile manifold – Kimal are anticipating this option will be available from 12 May 2026.
  • Current supply arrangements.
• Please see our Downloads Section to review the customer update.

NHSSC: 3

MHRA:
2026/004/017/601/053 – Namic White Star Handle Manifolds
2026/004/017/601/048 – Rotating Adaptor Syringes

Update:

• Kimal has issued updates to two Field Safety Notices (FSNs) and a cover note regarding Namic White Star Handle Manifolds and Namic Rotating Adaptor Syringes.
• Due to the risk of serious injury or death, customers are directed to remove and destroy all Namic White Star Handle Manifolds and Namic RA Syringes. Over-labels will be provided for any affected procedure packs/medical devices on hand stating that the affected syringes must be removed and discarded from further use.
• The only exception to this is in rare circumstances, or where an emergency procedure must be performed, no alternative device is available, and postponing the procedure would place the patient at significant risk.
• In such cases, clinicians must adhere to the instructions contained within the Field Safety Notices.

Next Steps:

• Read and follow the full instructions in the updated Field Safety Notices and share with all users of the affected products.
• Identify and quarantine all affected products and batches listed in Appendix 2 of the FSNs.
• Complete the User Form (Appendix 1) and indicate the number of units (Appendix 2) in your stock to receive the necessary quantity of “warning stickers”.
• Return the completed Appendix 1 and Appendix 2 (if applicable) by e-mail to vigilance@kimal.com as soon as possible.
• If you no longer have any of the impacted products in stock, please also complete the User Form (Appendix 1) and return by e-mail to vigilance@kimal.com as soon as possible.
• Upon the receipt of your submitted response form, Kimal will send over-labels to you with instructions for your staff to place onto the procedure pack.
• For products that are to be destroyed, please also contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including NPC, lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number.
• Dispose of the affected products in accordance with your local regulations. Upon written confirmation of disposal in the form of an email, quoting the CMS reference, your Customer Services Advisor will raise the appropriate credit.

NHS Supply Chain Reference: 3

Alert:

• Kimal has issued a Field Safety Notice and made us aware of three further Field Safety Notices issued by Medline regarding the recall of specific batches of Namic White Star Handle Manifolds and Namic Rotating Adaptor Syringes.
• Medline has identified through post-market surveillance:
  • For affected Namic Angiographic Control Syringe with Rotating Adaptor (RA) fitting (Namic RA Syringes) a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
  • For affected Namic White Star Handle Manifolds, identified a potential risk of foreign particulate within the fluid pathway of Namic White Star Manifolds.

Products Affected:

• There are 46 eDirect NHS Supply Chain products affected.
• 17 of the affected products are deactivated and not available via our online catalogue.
• Some of the affected products are trust specific and are not available to everyone.
• Please refer to the product listing and four Field Safety Notices for more information on the affected products.
• Due to the nature of the affected products and procedure packs affected, please contact customerservices@kimal.com for alternative products.
• Kimal have stock of various procedure packs, which they are offering to customers and mapping out the closest alternative.
• The supplier is expecting further stock of the affected products to be available mid-May 2026.

Next Steps:

• Read and follow the full instructions in the Field Safety Notices and share with all users of the affected products.
• Please complete the customer response form, found on page 3 of the Kimal FSN and return to vigilance@kimal.com.
• Should you wish to return any affected products, please contact Kimal to arrange collection and inform your NHS Supply Chain Customer Service Advisor with full details to enable us to raise the appropriate credit.
• We are working with suppliers to support product availability and alternatives and will update this ICN with more information as soon as possible.

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.

NHSSC: 3

Alert:

• Kimal has made us aware of three Field Safety Notices issued by Medline regarding the recall of specific batches of Namic White Star Handle Manifolds and Namic Rotating Adaptor Syringes.
• Medline has identified through post-market surveillance:
  • For affected Namic Angiographic Control Syringe with Rotating Adaptor (RA) fitting (Namic RA Syringes) a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold
  • For affected Namic White Star Handle Manifolds, identified a potential risk of foreign particulate within the fluid pathway of Namic White Star Manifolds.

Products Affected:

• We are working with Kimal to identify all affected products supplied by NHS Supply Chain.
• Some of the affected products are contained within procedure packs.
• Please refer to the three Medline Field Safety Notices for more information on the affected products in the meantime.

Next Steps:

• Read and follow the full instructions in the Field Safety Notices and share with all users of the affected products.
• For support regarding this recall please contact vigilance@kimal.com.
• Should you wish to return any affected products, please contact Kimal to arrange collection and inform your NHS Supply Chain Customer Service Advisor with full details to enable us to raise the appropriate credit.
• We are working with the supplier to support product availability and will update this ICN with more information as soon as possible.

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.