FDA-Device2013-06-12Class II
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.
I-Flow LLC
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.
Sold states
Nationwide distribution: USA including states of: CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.
Affected count
75 units
Manufactured in
20202 Windrow Dr, N/A, Lake Forest, CA, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1445-2013Don't want to check this manually?
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