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 Poses Immediate 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. Disconnection could lead to loss of fluid control, potential patient harm, and procedural failure during critical cardiovascular interventions.
This defect affects procedures in hospital quality and safety protocols, where device integrity is fundamental to patient outcomes. The manufacturers have advised hospitals to immediately segregate affected stock.
Manifold Contamination Risk Threatens Procedure Sterility
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. Particulates could enter the patient bloodstream, causing embolic events, vessel damage, or systemic inflammatory responses.
Related clinical updates on device safety emphasize that manifold integrity is critical in angiographic and interventional radiological procedures where fluid pathways must remain sterile and unobstructed throughout the intervention.
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. Healthcare institutions must conduct risk assessments for each potential use case and document clinical justification.
Medline Industries LP and Kimal PLC have committed to providing replacement stock and comprehensive guidance to affected UK hospitals. Clinicians requiring more detailed information should consult 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
- Emergency-only use restriction applies pending full investigation and corrective action by manufacturers
- Hospitals must immediately segregate affected stock and document clinical justification for any emergency use
Frequently asked questions
Why is syringe disconnection a critical risk in angiography?
Disconnection of the syringe during angiographic procedures results in loss of contrast control, inability to visualize vessels, and potential vessel perforation or thrombosis. In emergency coronary or cerebral interventions, such loss of control can lead to acute patient deterioration and serious adverse events.
What are the clinical consequences of foreign particulates in manifold devices?
Foreign particles within the manifold fluid pathway can be injected directly into patient coronary or cerebral vasculature, causing microvascular embolism, tissue ischemia, or inflammatory complications. Risk is particularly high in interventions requiring multiple injections or prolonged manifold use.
How should hospitals handle existing stock of affected Kimal Procedure Packs?
According to the MHRA notice, hospitals must immediately segregate all affected packs, verify serial numbers against manufacturer lists, and restrict use to documented emergency situations only. Healthcare institutions should contact their procurement and interventional radiology teams to plan transition to compliant replacement devices.
Medline Industries LP and Kimal PLC have stated that corrective action and replacement devices will be distributed to UK healthcare providers within a defined timeline. Hospitals should monitor communications from manufacturers and the MHRA for updates on product availability and investigation outcomes.
