The MHRA has replaced earlier advice on Belzer UW Cold Storage Solution and Belzer MPS machine-perfusion solution after corrective action addressed previously identified defects.
Earlier reports involved leakage and discoloration that could indicate contaminated fluid and a risk of significant patient harm. The regulator says corrective steps by Carnamedica and Bridge to Life have allowed the suspension on sales to be lifted.
Transplant and organ-retrieval teams should continue routine checks before use. Each bag should be inspected for discoloration, particles, leakage and mould or contamination around the connectors; any defective bag should be quarantined and reported.
The updated notice replaces DSI/2023/005. It does not remove the need for local quality controls, incident reporting or the manufacturer's current instructions for use during organ donation and transplantation procedures.
