I-Flow ON-Q Pump with ONDEMAND Bolus Button: Class I Recall - Risk of Continuous Infusion at a Rate Greater Than Expected
MedSun: Newsletter #76, September 2012

FDA MedWatch Safety Alert

FDA notified healthcare professionals that the I-Flow ON-Q Pump with ONDEMAND Bolus Button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowest most position. When this occurs, the patient may receive continuous infusion at a rate greater than expected. As a result, this product may cause serious adverse health consequences, including death. See the Recall Notice for a listing of affected product numbers.

Additional Information:

FDA MedWatch Safety Alert. I-Flow ON-Q Pump with ONDEMAND Bolus Button: Class I Recall - Risk of Continuous Infusion at a Rate Greater Than Expected. August 31, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm317851.htm


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