FDAnews
www.fdanews.com/articles/137001-mhra-issues-alert-for-level-1-normothermic-iv-fluid-administration-sets

MHRA Issues Alert for Level 1 Normothermic IV Fluid Administration Sets

May 23, 2011
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for Smith Medical’s Level 1 Normothermic IV fluid administration sets for use with Level 1 fast flow fluid warmer units due to risk of serious injury or death if using the IV sets that are not equipped with the F-50 gas vent filter assembly. Smith Medical recently updated a February field safety notice because the recommendation to use the original Non-F-50 disposables while the F-50 disposables were not available was found to be dangerous.