FDA Announces Recall of I-Flow ON-Q Pump With ONDEMAND Bolus Button

FDA has announced a Class I recall of the I-Flow ON-Q pump with ONDEMAND bolus button, according to an FDA release.

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The I-Flow ON-Q pump with ONDEMAND bolus button was manufactured from Oct. 18, 2002 through April 30, 2012 and distributed from May 3, 2010 through May 1, 2012.

 

It is used for continuous and intermittent delivery of medicines to or around surgical wound sites and/or to nearby nerves for pre-operative, during the procedure/surgery and for post-operative regional anesthetic and pain management.

 

The reason for the recall is I-Flow Corp. 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.

 

On May 8, 2012, the firm sent an important voluntary recall notice (pdf) to its customers who purchased the ON-Q pump with ONDEMAND bolus button.

 

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