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Early Alert: IV Tubing Set Issue from ICU Medical
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 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 is investigating these findings to determine if there is biological contamination, or if the reported material could enter the fluid path which could be a risk to patients.
As of May 15, ICU Medical has not reported any serious injuries or deaths associated with this issue.
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.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact ICU Medical at productcomplaintsPP@icumed.com or 1-866-216-8806.
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