The affected products and recommendations for what to do with the devices below have changed. The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems.
Affected Product
The FDA is aware that ICU Medical has issued a customer communication recommending updated use instructions for certain IV tubing sets.
Affected products:
- Plum Administration Sets with drip chambers
- IV Non-Dedicated Gravity Administration Sets with drip chambers
- IV Sets with drip chambers
- Oncology Sets with drip chambers
What to Do
Products may continue to be used in accordance with their intended use and standard clinical procedures.
In May and June 2026, ICU Medical issued several communications concerning reports of small 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.
On July 28, ICU Medical issued a final update letter to customers recommending the following actions:
- Consistent with standard clinical practice, users should always review devices prior to clinical use.
- If any loose particulate matter is observed in the fluid path, the individual device should be segregated, and ICU Medical should be contacted so the sample can be returned for investigation.
- Healthcare providers may continue using products in accordance with the Instructions for Use and established clinical procedures per facility protocol.
- No product returns are necessary.
- Share this notification with all potential users of the device.
Reason for Correction
In May 2026, ICU Medical received reports of small 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. The concern involved black specks and particulate matter within the drip chamber wall, raising questions about whether these findings represent biological contamination or could enter the fluid path and pose a risk to patients.
ICU Medical conducted an investigation that included evaluation of returned samples, laboratory analysis, simulated-use testing, and inspection of product inventory, and has determined that the reported discoloration is intrinsic to the PVC used to manufacture the drip chamber and remains embedded within the drip chamber wall. The investigation demonstrated that the reported observations represent discoloration of the drip chamber material itself and the discolorations:
- Are not biological contamination
- Are not foreign material
- Do not enter the fluid path
- Do not dislodge under expected use conditions
- Do not affect the structural integrity or performance of the drip chamber
ICU Medical has completed its investigation of reported discoloration observed in certain IV tubing set drip chambers. Based on this investigation, the observed discoloration is characteristic of the drip chamber material, does not enter the fluid path, and does not affect device safety, performance, or intended use.
Given these findings, ICU Medical no longer recommends the enhanced inspection activities described in prior communications. Products should continue to be used as intended and per facility protocol.
The investigation did not identify direct patient risk associated with use of affected products. In some circumstances, a healthcare provider who observes discoloration may elect to replace a product before use, which could result in a delay in therapy. These delays could be clinically significant, especially for time-sensitive, life-saving infusions or when a replacement cannot be readily obtained.
As of July 16, 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 using the information below:
| ICU Medical Contact | Contact Information | Areas of Support |
|---|---|---|
| Global Complaint Management |
GlobalComplaints@icumed.com 1-866-261-8806 |
Report on adverse events or product complaints |
| Customer Service |
customerservice@icumed.com 1-800-258-5361 |
Additional information or technical assistance |
| Field Action Processing |
MarketAction@mailac.custhelp.com | Assistance with customer notifications and response forms |
Additional FDA Resources
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.
Timeline of Communication Updates
| Date | Actions |
|---|---|
| 10/05/2026 | The FDA updated this communication to include new information on the reason for the correction, provide updated recommendations, and to inform the public that this issue has been classified as a Class II Recall. |
| 05/27/2026 | The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue. |
