Medline Industries is recalling the Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution (Lot 3B085) due to being non-sterile. The affected lot passed sterility testing, however, another lot within the same cleaning cycle (Lot 3B087) failed sterility testing, exposing the affected lot to potential contamination.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.