The Flushmate II 501-B system can burst at or near the vessel weld seam releasing stored pressure. This pressure can lift the tank lid and shatter the tank, posing impact and laceration hazards to consumers and property damage.
The Danish Medicines Agency has decided to lift the suspension of EuropharmaDK's manufacturing and importation authorisation, following the outcome of a follow-up inspection of EuropharmaDK ApS on 8 March where the Danish Medicines Agency ascertained that the critical findings had been corrected.
Danish Medicines Agency
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