CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

The FDA is aware that ICU Medical has issued a customer communication recommending certain IV tubing sets be removed from where they are used or sold.

ICU Medical and the FDA are still assessing the scope of this potentially high-risk device issue to identify certain models, lots, or UDIs that may be affected.

What to Do

Inspect all IV tubing sets for any evidence of compromise. Segregate any items with anomalies, complete a MedWatch complaint, and contact ICU Medical to return the sample for investigation.

On May 15, ICU Medical issued a customer communication on their website recommending the following actions:

Users should inspect all devices prior to use for any evidence of compromise, including but not limited to marks or black specks on the chamber walls, particulate matter within the drip chamber or fluid path, and condensation within the device.
If users visually identify any anomalies, they should segregate the individual item, complete a MedWatch complaint following the hospital facility process and contact ICU Medical to return the product sample for investigation.
Contact ICU Medical at [email protected] or online at https://icumed.custhelp.com/app/complaint or by calling 1-866-216-8806 to report the event and to arrange the return of the product for investigation.
To file a MedWatch report, please contact FDA at www.fda.gov/medwatch or 1-888-INFO-FDA (463-6332).

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Alert

ICU Medical has received reports of black specks and discoloration observed on the inner wall of drip chambers, as well as particulate matter found within the drip chambers in certain IV tubing sets. ICU Medical stated that they are conducting an investigation to assess whether these findings represent biological contamination or could enter the fluid path and pose a risk to patients.

At this time, neither ICU Medical nor the reporting healthcare facility have identified evidence indicating that the reported condition represents a risk of biological contamination; however, this has not been ruled out.

As of May 15, ICU Medical has not reported any serious injuries or deaths associated with this issue.

Device Use

IV tubing sets are sterile tubes that connect to IV fluid or medication bags and deliver fluids, medications, or blood into a patient’s vein.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact ICU Medical at [email protected] or 1-866-216-8806.

Additional Company Resources

Company-provided information is posted here by the FDA as a public service.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.