FDA designates Class 1 recall for infusion pumps due to air bubble risk

Editor's Note

The US Food and Drug Administration (FDA) has deemed Zyno Medical’s recall of Z-800, Z-800F, Z-800W, and Z-800WF infusion pumps a Class 1, the most severe designation indicating serious risk of injury or death.

According to FDA’s October 11 announcement, the recall was due to  a defect in the air-in-line software algorithm that may allow a 1.0 mL air bubble to be passed on to a patient. Potential consequences include vascular air embolism, tachyarrhythmia, myocardial infraction, stroke, seizure, and death. Two injuries and no deaths have been reported.