FDA: Class I recall of Smiths Medical Sterile Saline and Water for Inhalation

Editor's Note

The Food & Drug Administration (FDA) on February 4 identified the recall by Smiths Medical (Minneapolis, Minnesota) of certain lots of Sterile Saline and Water for Inhalation as Class I, the most serious.

The recall was initiated because of potential exposure to infectious agents (bacillus infantis and staphylococcus epidermidis) as a result of leaking containers.

The products, which are used in patients undergoing respiratory therapy, tracheal wash, or wound cleaning, were distributed between August 30, 2013 to February 10, 2017. On January 7, 2019, distributor Medline Industries initiated a sub-recall for privately labeled product models and lots that were affected by the Smiths Medical recall and had not expired.