FDA Deems Medline Industries’ Saline Solution Vial Recall as Class 1

September 25, 2023

Medline Industries’ recall of 18,000 saline solution vials due to being non-sterile has been deemed as class 1 by the FDA, the most serious type of recall, because use of the device may cause serious injuries or death.

The use of non-sterile saline may cause difficulty breathing, general discomfort, nausea, wheezing, and infection. Infection can lead to life-threatening sepsis, and death.

The affected lot of Hudson RCI Addipak unit dose vial, 0.9% full normal saline, distributed between April 20 and July 14, passed sterility testing, but, another lot within the same cleaning cycle failed sterility testing, exposing the affected lot to potential contamination.

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