Tuesday, September 14, 2010

Symbiq One- and Two-Channel Infusers Recalled

Symbiq One- and Two-Channel Infusers manufactured by Hospira are subject to a class 1 US Food and Drug Administration (FDA) recall because of a potential for the failure to detect air in the line at the end of an infusion. An alert sent September 10 from MedWatch, the FDA's safety information and adverse event reporting program, indicates that the recall was initiated on April 9, 2010, and affects model number 16026 Symbiq One-Channel Infuser and 16027 Symbiq Two-Channel Infuser.

The manufacturer mailed an updated clinical bulletin on June 11, 2010, which stated that the user does not have to remove or stop using the Symbiq infusion pump, and it provided recommended mitigation actions such as not running solution/medication containers dry and programming the pump for 95% of stated volume of container (minus the priming volume) or less.

To date, no reports of serious injuries have been received, but the manufacturer states that "failure to detect air in line may result in the delivery of air to the patient, resulting in serious injury or death.
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