The Recall Desk

FDA (Devices) recall action 64826

I-Flow LLC recalled 2 products on 2013-06-12

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-06-12
Critical
0
Units
525

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··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.

    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.
    Category
    Distribution
    13 states
  • HighFDA (Devices)··2013-06-12

    I-Flow ON-Q Pain Relief System T-Block Needle/Catheter Kit Recalled

    I-Flow LLC is voluntarily removing 75 units of the ON-Q Pain Relief System T-Block Needle/Catheter Kit because they may have potentially malfunctioned.

    Product
    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.
    Category
    Distribution
    13 states