Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

I-Flow ON-Q Pain Relief System Recalled by I-Flow LLC Due to I-Flow initiated two voluntary product removals of the...

Date: June 1, 2012
Company: I-Flow LLC
Status: Terminated
Source: FDA (Device)

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 LLC directly.

Affected Products

I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T 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.

Quantity: 75 units

Why Was This Recalled?

I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About I-Flow LLC

I-Flow LLC has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report