The Recall Desk
HighFDA (Devices)·Z-1444-2013·Announced 2013-06-12

I-Flow ON-Q Pain Relief System T-Block Needle/Catheter Tray Recall

I-Flow LLC is voluntarily removing 450 units of the ON-Q Pain Relief System T-Block Needle/Catheter Tray because the devices may have malfunctioned.

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 with a potential malfunction risk where no specific injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

I-Flow LLC is voluntarily removing 450 units of the I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T, from the market. The recall was initiated because the devices may have potentially malfunctioned.

The affected units are identified by Lot # AW207202O. These products were distributed nationwide across the United States, specifically in the states of California, Connecticut, Florida, Illinois, Indiana, Kentucky, New York, Ohio, Oregon, Tennessee, Texas, Virginia, and Wisconsin.

Consumers who have this specific product should stop using it and contact I-Flow LLC for further instructions regarding the voluntary removal.

The recalled product

Product
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
Manufacturer
I-Flow LLC
Category
Medical Device — Pain Management
Hazard
Affected units
450

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot # AW207202O

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 2 recalled by I-Flow LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · I-Flow LLC

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Same hazard · malfunction

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