McKesson had previously filed a Class II recall voluntarily last March following the incident, and issued a corrective patch to 10 affected customers. In a statement, McKesson states no patient harm resulted from the incident, and the company is closely monitoring the software.
Class I is the FDA’s highest level of recall, used when there is “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” McKesson is currently working with the FDA to close the Class I recall.
More Articles on the FDA:
AHA Seeks FDA Action on Saline, IV Solution Shortage
FDA Approves Implantable Device for Certain Type of Hearing Loss
6 Senators Press for Clarity Over FDA Regulation of Health IT
