FDA: Class I recall of Aligned Medical Solutions custom convenience kits

Editor's Note

The Food and Drug Administration (FDA), on November 9, identified the recall by Aligned Medical Solutions of its custom convenience kits as Class I, the most serious.

The recall was initiated because of the potential for the plunger in Cardinal Health's Monoject Flush Prefilled Syringe (0.9% sodium chloride), which is packaged in the kits, to draw back after the air has been expelled and reintroduce air into the syringe.

If clinicians are not aware of air coming back into the syringe, they could inadvertently push air into the vascular system and cause an air embolism.

There have been 42 reports of reintroduction of air into the syringe, and no reports of injuries or deaths.

Distribution dates were January 23 to October 19, 2020.