I-Flow Recalls ON-Q Pumps Due to Bolus Button Malfunction
I-Flow Corporation is recalling ON-Q pumps with ONDEMAND because the bolus button may fail to lock, causing patients to receive medication at higher-than-expected rates.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device malfunction that can lead to the administration of medication at higher-than-expected rates. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as no specific injuries or illnesses are cited in the source text.
Plain-English summary
I-Flow Corporation is recalling specific models of ON-Q pumps with ONDEMAND bolus buttons and ON-Q C-bloc devices. The recall affects 80,646 units total, with 65,926 units distributed in the United States. The products were distributed worldwide, including in Canada, Australia, Germany, the United Arab Emirates, and Cyprus.
The recall was initiated because it was determined that in a small quantity of these pumps, the bolus button may not lock in the down position when depressed, and/or the orange bolus refill indicator may remain in the lowermost position. As a result of this malfunction, patients may receive a continuous infusion of medication at a rate greater than expected.
The affected products are indicated for the continuous and/or intermittent delivery of medication to or around surgical wound sites and/or close proximity to nerves. Products with a 10-digit Lot number greater than 0200521454 (i.e., 0200521455 and greater) are not impacted by this recall.
The recalled product
- Product
- 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, 10
- Manufacturer
- I-Flow Corporation
Distribution
Distribution scope not specified by the agency.
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