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IV Flush faces uncertain future after 510(k) mistake

This article was originally published in Clinica

Executive Summary

A Dallas, Texas-based company, established less than a year ago to make preloaded syringes containing heparin and sodium chloride flushes for intravenous catheters, could be on the verge of closure after reported cases of contamination alerted the FDA to the fact that it had not obtained 510(k) clearance for its devices.





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