ICU Medical issued an update on its July 29 recall of 48 lots of its Plum and Sapphire Microbore infusion sets with inline filters because of the potential for fluid leakage.
The devicemaker noted that no adverse events were reported regarding the defects, but that the FDA is still “actively evaluating” the issue in an effort to classify the recall.
The two infusion systems may leak a small amount of fluid out of the air vents on their inline filters. The fluid leakage could cause delay of infusion, medication under-delivery, contamination of the fluid path which is on the patient side of the filter, or exposure to hazardous medications, ICU Medical said.
It urged users to return the affected products to Stericycle for credit.