Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
ON-Q pump with ONDEMAND bolus button Recalled by I-Flow Corporation Due to It was determined that in a small quantity...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact I-Flow Corporation directly.
Affected Products
ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.
Quantity: 80,646 units total (65,926 units in US)
Why Was This Recalled?
It was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. As a result, the patient may receive continuous infusion at a rate greater than expected.
Where Was This Sold?
Worldwide Distribution -- USA, Canada, Australia, the EU (Germany), United Arab Emirates, and Cyprus.
About I-Flow Corporation
I-Flow Corporation has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report