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# ICU Recalls Infusion Sets Over Leak Issue
- URL: https://www.fdaweb.com/icu-recalls-infusion-sets-over-leak-issue/
- Published: 2019-10-10T12:00:00.000Z
- Updated: 2026-09-15T01:55:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145224

ICU Medical has recalled certain lots of Plum and Sapphire Microbore Infusion Sets with inline filters due to the potential for fluid leaks through air vents on the inline filters. To date, the company has not received any adverse event reports related to the issue, a [recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/icu-medical-issues-voluntary-nationwide-recall-certain-lots-plum-and-sapphire-microbore-infusion?utm%5Fcampaign=FDA%20MedWatch%20-%20Plum%20and%20Sapphire%20Microbore%20Infusion%20Sets%20with%20Inline%20Filters%20by%20ICU%20Medical&utm%5Fmedium=email&utm%5Fsource=Eloqua) says. Fluid leakage could cause an infusion delay, medication under-delivery, contamination of the fluid path which is on the patient side of the filter, exposure to hazardous medications, or fluid path air-in-line issues.