The South Dakota Department of Health’s Office of Disease Prevention Services – shared information with the health care community regarding concerns for gross contamination of intravenous tubing sets.
Update shared Wednesday, May 13, 2026.
Yesterday the CDC shared an alert regarding the potential for IV tubing contamination involving product lot numbers. Since that time, the manufacturer has completed an evaluation and has indicated the identified lot numbers are considered safe for use. At this time, no adverse events or patient injuries have been reported related to this issue.
The manufacturer’s response statement and additional information can be accessed here: ICU Medical CDC Response to IV Tubing Set Drip Chambers
While no additional action is currently recommended, this serves as an important reminder that all medical supplies and devices should be routinely inspected prior to use to help ensure patient safety. Facilities should continue to follow standard practices by checking products for any abnormalities, damage, discoloration, particulate matter, compromised packaging, or other concerns before use. Products that appear abnormal in any way should not be used out of an abundance of caution and should be reported through the appropriate facility channels.
Details below were shared on Tuesday, May 12, 2026.
South Dakota has been notified by the CDC and Maine and Pennsylvania HAI/AR programs of multiple healthcare facilities reporting visible contamination of IV tubing from the same manufacturer. The contamination is reported as small black dots on the internal walls of the drip chambers. In Maine, the healthcare facilities through their investigation have now identified at least 15 different lot numbers impacted from the same manufacturer. CDC has not received any reports of patient infections or adverse events linked with the contaminated product. The manufacturer and FDA have been made aware.
At this time, the impacted products appear to be limited to tubing manufactured by ICU Medical, distributed by Medline. The respective states are still gathering lot numbers. Preliminary information about product types is below.
The ICU Medical product types 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
The SD HAI/AR program is recommending that facilities check the supplies used by their facilities and if IV tubing and products manufactured by ICU Medical, that you physically inspect your supplies for any visible contamination as soon as possible. If visible contamination is seen, facilities should stop the use of the affected products, immediately alert ICU Medical, and file a FDA Med/Watch report.
Please notify the South Dakota Department of Health HAI/AR program at cheri.fast@state.sd.us if contaminated products are found in your inventory.
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
