Device 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.
Z-1444-2013
Product summary
- Firm
- I-Flow LLC
- Event
- Event 64826
- Status
- Terminated
- Classification
- Class II
- Quantity
- 450 units
- Official record key
device-enforcement:Z-1444-2013
Official wording
Reason: 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.
Code information: Lot # AW207202O
Distribution pattern: Nationwide distribution: USA including states of: CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.
Derived failure modes
-
Unknown
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.