A class I recall has been issued for the I-Flow ON-Q pump with ONDEMAND bolus button. The I-Flow Corporation determined that the ON-Q pumps 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.
The On-Q pump with ONDEMAND bolus button is used for continuous and intermittent delivery of medicines (such as local anesthetics or narcotics) to or around surgical wound sites and/or to nearby nerves for pre-operative, during the procedure/surgery (perioperative), and for post-operative regional anesthetic and pain management.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
This recall affects ON-Q pump with ONDEMAND bolus button units manufactured from October 18, 2002, through April 30, 2012, and distributed from May 3, 2010, through May 1, 2012.
See the recall