This article is more than 5 years old. Information may no longer be current.
Nitric oxide delivery system recalled for potential interruption of drug flow
Click Here to Manage Email Alerts
The manufacturer of a nitric oxide drug delivery system has notified health care professionals of a voluntary class I recall of its system because of the potential for failure of a pressure switch that monitors when the drug supply should be replaced. The possible failure could interrupt drug flow due to an empty cylinder or the time it takes to switch to a replacement system, according to an FDA press release.
The nitric oxide system, INOMAX (Ikaria), is a vasodilator used in conjunction with ventilator support and other agents for the treatment of term and near-term neonates with hypoxic respiratory failure. If the administration of nitric oxide is interrupted or delayed in these patients, it could cause:
· Worsening of low blood oxygen level.
· Hypotension.
· Pulmonary hypertension.
· Death.
A recall notice was issued to customers on July 21. The notice described the issue, how to recognize the problem, what to do and how to reduce potential risks associated with system failure. The notice also explained the long-term repair of replacing all nitric oxide drug delivery systems, which the company has begun to do. The INOvent drug delivery system is not included in the current recall.
The risk of nitric oxide exposure to pregnant women is unknown, so the company advises health care professionals who may be pregnant to avoid the immediate area of a suspected leak. In addition, the company urges health care professionals who suspect a leak to not interrupt the delivery of nitric oxide, ensure there is an adequate amount of the product in the cylinder and switch to the manual backup system. The company’s customer care department should be contacted for assistance.
 |
Follow CardiologyToday.com on Twitter. |