FDA records place the USVI in an IV-tubing product correction

Federal recall records list the U.S. Virgin Islands among distribution areas for ICU Medical IV tubing sets covered by an updated-use instruction after brown discoloration was reported in some drip chambers and tubing components.

The FDA notice covers certain Plum administration sets, non-dedicated gravity sets, IV sets and oncology sets with drip chambers. ICU Medical says the color comes from the PVC material itself, is not contamination or foreign matter, and does not enter the fluid path or affect product performance.

The products do not need to be returned and may continue to be used. Healthcare workers should follow standard pre-use inspection procedures; any set with loose particulate in the fluid path should be isolated and reported to ICU Medical.

FDA classifies the action as a Class II recall, meaning temporary or medically reversible harm is possible but serious harm is unlikely. No serious injuries or deaths had been reported as of July 16. The public record does not identify which USVI facilities received the sets or how many remain in local inventory.