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IV Tubing Set Correction: ICU Medical Updates Use Instructions for IV Tubing Sets
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
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.
The affected products and recommendations for what to do with the devices in this communication have changed. The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems.
Questions?
Customers in the U.S. with questions about this recall should contact ICU Medical at GlobalComplaints@icumed.com or (866) 261-8806 to report adverse events or product complaints. Customers should contact ICU Medical at customerservice@icumed.com or (800) 258-5361 for additional information or technical assistance.
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