The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2253-2012·Announced 2012-09-05

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

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…
Manufacturer
I-Flow Corporation
Category
Medical Device — Drug Delivery Pump
Hazard

Distribution

Distribution scope not specified by the agency.

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