MHRA Lifts Suspension on Belzer Organ-Preservation Fluid

MHRA told UK transplant centres on 6 August that they can once again buy Carnamedica’s Belzer UW Cold Storage Solution and Belzer MPS, a UW Machine Perfusion Solution used to preserve donated organs before transplant. Field safety notice DSI/2026/006 lifts a sales suspension that traces back to a contamination defect MHRA first flagged in 2023 — closing a supply gap that ran three years for a product transplant programmes depend on.

A three-year gap in a niche but critical supply chain

Belzer UW Cold Storage Solution and Belzer MPS belong to a small category of products with an outsized role: the fluids that keep a donated kidney, liver, or pancreas viable between retrieval and transplant. MHRA first raised concerns about the Carnamedica-manufactured solutions in 2023, in a notice designated DSI/2023/002 and then updated as DSI/2023/005. The defects described were physical and visible — leakage from containers and discolouration of the fluid — but the consequence was a contamination risk MHRA judged serious enough to warrant a UK sales suspension while Carnamedica and Bridge to Life investigated and corrected the manufacturing issue.

That correction took three years to close out publicly. DSI/2026/006, published 6 August, states that MHRA has reviewed all the data supplied over the course of the investigation and concluded the sales suspension can now be lifted. The notice does not name the specific manufacturing fix; it does confirm the product is again available to purchase from Bridge to Life in the UK.

What the notice asks of transplant teams now

Lifting a suspension is not the same as declaring the underlying risk retired. MHRA’s notice tells healthcare professionals to keep checking for the same signs — leakage, discolouration — during routine pre-use inspection of each unit, and to report any defective product through the channels the agency uses for device vigilance: the Yellow Card scheme for England, Northern Ireland, and Wales, or IRIC in Scotland, plus direct notification to NHS Blood and Transplant and to Bridge to Life. That is the same reporting architecture MHRA leaned on weeks earlier for a ventilator-failure risk in Dräger’s Atlan anaesthesia workstations — a reminder that a field safety notice’s job does not end at publication; it ends when the vigilance loop it opens actually closes.

For regulatory and quality teams at transplant centres and organ-procurement organisations, the practical read is narrower: a previously suspended, single-source-adjacent product is back on the approved-supplier list, and the pre-use vigilance obligation that came with the original 2023 alert does not lapse just because the suspension has.