Regulatory Alert Issued for Contaminated Carnamedica Belzer UW Solutions

Today we’ve issued a regulatory alert regarding contamination issues with Carnamedica Belzer UW Cold Storage and Machine Perfusion solutions imported by Bridge to Life. Discolouration of solution/microbial contamination and leaking bags have been found in the 1L size of the Cold Storage Solution, while particulate matter has been found in the 2L size of the same solution.

 

On 20 January 2023, Bridge to Life temporarily suspended the supply of specific manufacturing lots of the two solutions to the UK. The manufacturer is currently conducting an investigation and findings will be reported to the Medicines and Healthcare Products Regulatory Agency for review. The HTA has issued the alert to HTA-licensed establishments for wider awareness and advised users to contact Bridge to Life for further advice and follow the guidance issued by the company and the MHRA.

 

Further details on the regulatory alert can be found on the regulatory alerts and updates page