The FDA's criticism of Cardinal Health for not ensuring that syringes in their convenience kits have the necessary 510(k) clearance indicates a significant oversight in regulatory compliance. This situation could lead to potential fines, mandatory recalls, or other regulatory actions, which would negatively impact the company's financial performance and reputation in the short term. The direct mention of this issue by the FDA suggests a high relevance to Cardinal Health, and the nature of the oversight underlines its importance to investors, given the potential for significant financial and reputational repercussions.