ICU Medical (NSDQ:ICUI) said today that it is recalling certain lots of its Plum and Sapphire microbore infusion sets with inline filters due to the potential for small amounts of fluid to leak from the filters’ air vents.
San Clemente, Calif.-based ICU Medical said it is not aware of adverse events related to the problem, but that the FDA is evaluating the information in an effort to classify the recall. Fluid leakage may potentially cause delay of infusion, medication under-delivery, contamination of the fluid path on the patient side of the filter, exposure to hazardous medications, or air in the fluid path line.
The list of affected product lots, which were distributed nationwide, may be found here.