|I-Flow is recalling its ON-Q pumps over the risk of over-infusion--courtesy of I-Flow|
I-Flow has recalled its ON-Q Pump with OnDemand Bolus Button, and the FDA says a malfunction in the device could lead to serious injury or death.
In May, I-Flow initiated a voluntary recall, warning customers that the ON-Q's button may not lock in the down position, possibly leading to patients getting a continuous infusion of anesthetics or narcotics when it's not expected. This week, the FDA labeled the recall a Class I, meaning it carries the risk of severe adverse events or death.
I-Flow is asking affected customers to quarantine the recalled devices and inform the company as soon as possible to set up a product return and credit. The FDA is urging patients and physicians to report any adverse events through its online MedWatch system.
The pump is designed to administer medicines to surgical wound sites before, during or after operations. The recalled devices were manufactured between October 2008 and April 2012, and they were distributed from May 2010 to May 2012, according to I-Flow.
- read the FDA recall notice
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