Updated 25/05/2026
Medline Industries LP and Kimal PLC have issued a critical field safety notice regarding defects in Namic Angiographic Control Syringes and Namic White Star Off Handle Manifold devices supplied in Kimal Procedure Packs, according to a safety alert issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The notice restricts use to emergency situations only, pending investigation and corrective action.
Safety Risks in Recalled Kimal Components
Two device types identified with distinct failure mechanisms affecting clinical procedures
Source: UK MHRA Field Safety Notice DSI/2026/002 | Georgian Medical Journal News
Syringe Disconnection Risk During Angiography
The Namic Angiographic Control Syringes with RA handle have a documented risk of disconnection during use in angiographic procedures, according to the MHRA alert. The manufacturers have advised hospitals to immediately segregate affected stock.
Manifold Contamination Risk
The Namic White Star Off Handle Manifold devices carry a separate risk of foreign particulate contamination within the device pathway, as documented in the same safety notice.
Emergency-Only Guidance Pending Full Corrective Action
The MHRA has determined that affected Kimal Procedure Packs may be used only in genuine emergency situations where clinical need outweighs device risk, pending a full investigation and corrective measures by manufacturers, according to the MHRA safety alert.
Medline Industries LP and Kimal PLC have committed to providing replacement stock and comprehensive guidance to affected UK hospitals, according to the full MHRA safety alert (DSI/2026/002).
Kimal Procedure Packs containing Namic Angiographic Control Syringes and Namic White Star Off Handle Manifold devices must not be used except in emergency situations due to documented risks of syringe disconnection and foreign particulate contamination.
— UK Medicines and Healthcare products Regulatory Agency (MHRA Field Safety Notice DSI/2026/002, 2026)
Key takeaways
- Two distinct device defects identified in Kimal Procedure Packs: syringe disconnection risk and manifold particulate contamination (MHRA DSI/2026/002)
- Emergency-only use restriction applies pending full investigation and corrective action by manufacturers (MHRA DSI/2026/002)
- Hospitals must immediately segregate affected stock according to manufacturer guidance (MHRA DSI/2026/002)
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Medically reviewed by Prof. Giorgi Pkhakadze, MD, MPH, PhD. Spotted an error? Contact the editorial team.
