Windstone Medical’s Convenience Kits Recalled Due to Syringe Plunger Defect

The FDA has issued an update on Windstone Medical Packaging’s recall of its custom convenience kits, deeming it a Class I recall because of the risk of serious injury or death.

The reason for the recall is that the kits contain the Cardinal Health Monoject Flush Prefilled Syringe (0.9 percent sodium chloride). The other components of the kit are not affected and have not been recalled.

The plunger of the Cardinal Health syringe may draw back after the air has been expelled and reintroduce air back into the syringe, which could lead to the clinician inadvertently pushing air into the vascular system, potentially causing an air embolism.

The 9,378 affected kits were distributed from Jan. 23 to Oct. 19, 2020. There have been 42 reports of plunger retraction and introduction of air into the Cardinal Health syringes, but no reports of complaints, injuries or deaths. Windstone is also known as Aligned Medical Solutions.