The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding certain IV tubing sets manufactured by ICU Medical, which are being assessed for a potentially high-risk device issue. ICU Medical has recommended the removal of these sets from use and sale after receiving reports of black specks, discoloration, and particulate matter observed within the drip chambers.
ICU Medical is currently investigating these findings to determine if biological contamination is present or if the reported material could enter the fluid path, posing a risk to patients. As of May 15, ICU Medical has not reported any serious injuries or deaths associated with this issue.
The FDA's Center for Devices and Radiological Health (CDRH) said, "CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue." The agency added that it "will keep the public informed and update this web page as significant new information becomes available." Customers with questions or adverse reactions should contact ICU Medical.