The FDA has issued an early warning regarding Medline Fluid Delivery Sets, which may pose a significant health risk due to a potentially incorrect assembly, according to a Dec. 30 news release from the agency.
The issue involves Fluid Delivery Sets with a white macro drip chamber, which were mistakenly included in some kits instead of the required grey micro drip chamber. The macro chip chamber delivers fluid at a rate three times higher than the micro drip chamber, increasing the risk of over-administration.
The FDA has flagged this as a potentially high-risk issue, as improper fluid delivery can lead to serious complications such as edema, shortness of breath, high blood pressure and in severe cases, death.
Medline has already notified healthcare providers, urging them to check their stock, identify the incorrect sets and discard any containing the white macro drip chamber. Products with the correct grey micro drip chamber can still be safely used.
While Medline has not reported any injuries, the FDA is closely monitoring the situation.