The U.S. Food and Drug Administration (FDA) has recently announced a Class I Recall in regards to the On-Q pump with ONDEMAND bolus button. These devices are typically used for the delivery of medicines (local anesthetics and narcotics) following a surgical procedure. However, the FDA has recently been made aware 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. The patient may then unknowingly receive continuous infusion at a rate greater than expected, resulting in serious and potentially fatal adverse health consequences.
If you or a loved one has been injured by an I-Flow On-Q Infusion pump, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
I-Flow ON-Q Infusion Pump Lawsuit Overview
As a product of the I-Flow Corporation, the On-Q pump with ONDEMAND bolus button was specifically designed to assist in the infusion of medicines following medical procedures. More specifically, these devices are used for both the intermittent and continuous delivery of local anesthetics and narcotics to wounds resulting from surgical procedures. The infusion pump also administers medications to localized nerve sites, in order to provide an adequate pain management strategy for those who need it.
Of significant concern, however, is an influx of adverse event reports that suggest these devices may exhibit a propensity for failure. According to a recent FDA Safety Communication, regulatory officials 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.
I-Flow ON-Q Infusion Pump Recall
Having received multiple adverse event reports regarding I-Flow ON-Q Infusion Pumps, the FDA has recently announced a Class I recall of the defective devices. The recall was effective as of May 8, 2012 and includes the following I-Flow ON-Q Infusion Pumps:
- I-Flow ON-Q Infusion Pumps with the following Model/Reference numbers: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30 P400X5+5/60, PMB01.
- I-Flow ON-Q Infusion Pumps with the following part numbers: 01347100, 101347300, 101347400, 101360200,101368400, 101368600, 101368700, 102987000,102987200, 102987300, 103161800, 103534300,5001438, 5001470, 5001651, 5001780, 5001808,
5001809, 5001812, 7000180, 7000181, 7000182,7000367.
- I-Flow ON-Q Infusion Pumps with an expiration date of 2014-04 or earlier.
The I-Flow ON-Q pump with ONDEMAND bolus button was manufactured from October 18, 2002 through April 30, 2012 and distributed from May 3, 2010 through May 1, 2012
Do I Have an I-Flow ON-Q Infusion Pump Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in I-Flow ON-Q Infusion Pump lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by an I-Flow ON-Q Infusion Pump, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.