Ongoing investigation of contaminated IV sets from ICU Medical

 

To: Infection preventionists From: CDPHE Healthcare-Associated Infection and Antimicrobial Resistance Program The Centers for Disease Control and Prevention (CDC) alerted state Healthcare-Associated Infections and Antimicrobial Resistance (HAI/AR) Programs that multiple healthcare facilities in Maine and Pennsylvania are reporting visible contamination of intravenous (IV) tubing from ICU Medical. The contamination is reported as small black dots on the internal walls of the drip chambers. Particulate matter appears embedded in the plastic material, and, in some reports, appears in the lumen or chamber of the tubing.  There have been no reports of patient infections or adverse events linked with the contaminated product. However, the presence of foreign material in infusion products may pose a health risk to patients. The manufacturer and the U.S. Food and Drug Administration have been made aware. As of May 8, 2026, no product recall has been issued. A public health investigation is ongoing. At this time, the impacted products appear to be limited to tubing manufactured by ICU Medical, distributed by Medline. Affected products identified to date include: Primary Set Piggyback with Backcheck Valve, 2 CLAVE Y-Sites, Secure Lock, 100 Inch Primary PLUM Set CLAVE Port, CLAVE Y-Site, Secure Lock, 103 Inch Secondary Set Secure Lock, 34 Inch with IV Set Hanger Maine healthcare facilities have identified at least 15 different lot numbers impacted from the same manufacturer.  Infection preventionists should identify whether their healthcare facility uses IV tubing products manufactured by ICU Medical and physically inspect ICU Medical IV infusion sets for visible contamination.  If visible contamination is identified,  Sequester the affected products,  Alert ICU Medical, and File a FDA MedWatch report. In addition, notify the CDPHE Healthcare-Associated Infections and Antimicrobial Resistance (HAI/AR) Program at cdphe_hai_ar@state.co.us, so that we can investigate further. For additional information, please see Maine’s Health Advisory Notice:  Ongoing Investigation of Contaminated IV Sets from ICU Medical | Maine Center for Disease Control & Prevention