Baxter ($BAX) has launched a recall of some of its disposable buretrol devices, warning that their valves can allow air to seep into the solution and lead to a dangerous air embolism. The FDA has labeled the recall a Class I, its most serious designation, saying the devices could cause serious injury or death.
The recall affects Baxter's Interlink and Clearlink buretrol solution sets manufactured between April 2003 and July 2012. Baxter launched the recall in September, warning customers to stop using the devices immediately. The FDA announced its Class I designation today.
The disposable devices are designed to infuse solutions into patients' veins, much like an IV. At issue is the devices' ball-valve feature, which Baxter found prone to malfunction. Instead of sealing off the buretrol tube, some of the valves allowed air to enter the device, putting patients at risk for painful and dangerous embolisms. Baxter did not disclose whether it had received any reports of this happening.
The FDA is asking patients and physicians to report adverse events through its online MedWatch system.
In August, Baxter conducted a Class I recall of its Automix compounder device, warning that a keypad malfunction could cause the device to improperly dose patients.
- read the FDA notice