FDAFDA · Food and drugs·Recall number Z-1445-2013
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.
Published June 12, 2013 · Recall initiated: June 1, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- I-Flow LLC
- Distributor
- Nationwide distribution: USA including states of: CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.
- Lot
- Lot # AW207202U
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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