I-Flow ON-Q Pump with ONDEMAND Bolus Button Recalled due to Risk of Continuous Infusion at a Great Rate

Risk Managers and Nursing healthcare personnel are informed by the FDA that I-Flow ON-Q Pump with ONDEMAND Bolus Button is recalled because there is a potential of continuous infusion at a rate greater than expected that may cause serious adverse events, including death.

Background of I-Flow ON-Q Pump with ONDEMAND Bolus Button

ON-Q Pump with ONDEMAND Bolus Button, by I-Flow Corporation, is used for continuous and intermittent delivery of medicines in order to manage pain before, during and after the procedure/surgery. FDA Alert on I-Flow ON-Q Pump with ONDEMAND Bolus Button

FDA’s reason for the recall is that the I-Flow ON-Q Pump with ONDEMAND Bolus Button may not lock in the down position when depressed leading to continuous infusion at a rate greater than expected. This can cause serious adverse events.

The affected models are: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60 and PMB01.

The affected part numbers are: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182 and 7000367.

The manufacture dates were from October 18, 2002 to April 30, 2012 and the distribution dates were from May 3, 2010 to May 1, 2012.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on I-Flow ON-Q Pump with ONDEMAND Bolus Button

“On May 8, 2012, the firm sent an IMPORTANT VOLUNTARY RECALL NOTICE to its customers who purchased the ON-Q pump with ONDEMAND bolus button. Customers should identify all affected products within your inventory and Quarantine the affected products.”

Contacting the FDA to report cases with I-Flow ON-Q Pump with ONDEMAND Bolus Button

In case of detection of adverse events or side effects related to the use of I-Flow ON-Q Pump with ONDEMAND Bolus Button, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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