
The FDA slapped Mindray Medical’s (NYSE:MR) anesthesia delivery system recall with Class I status after the federal watchdog agency deemed a gasket leak in the devices a potential hazard to patients.
Although there have been no reported injuries associated with the gasket leak, the FDA warned that the defect could reasonably cause patients harm.
Mahwah, N.J.-based Mindray initiated the recall with a letter to customers early in August, warning that its A3 and A5 anesthesia systems may have a gasket leak that could cause interruptions in gas delivery and patient ventilation. The leaking gas may also cause injury to operating room personnel and bystanders, the FDA noted.
The device maker traced the cause of the leak back to a "a small step in the gasket surface which may interfere with the full seating of the gasket within the canister," according to the FDA notice.
The affected systems were shipped between May 31, 2011 and July 15, 2012 in the U.S., Latin America and Australia. Mindray issued a press release regarding the recall earlier this month, by which time the company said it had already corrected about 70% of the units in the field by replacing the canister gaskets.
MR shares were up 0.8% to $33.93 as of about 12:30 p.m. today.