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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential malfunction risk where no injuries or illnesses have been reported, fitting the rubric criteria for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
I-Flow LLC has initiated a voluntary product removal of the ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T. The recall affects 75 units from Lot # AW207202U.
The company is removing these products because they may have potentially malfunctioned. The source text does not specify the nature of the malfunction or report any injuries or illnesses associated with the use of these devices.
The affected units were distributed nationwide in the United States, specifically in the states of CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA, and WI. Consumers who possess this specific lot number should stop using the product and contact I-Flow LLC for further instructions.
The recalled product
- 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.
- Manufacturer
- I-Flow LLC
- Category
- Medical Device — Pain Management
- Hazard
- Affected units
- 75
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # AW207202U
Distribution
Part of a larger recall action
This product is one of 2 recalled by I-Flow LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · I-Flow LLC
See all →- HighI-Flow ON-Q Pain Relief System T-Block Needle/Catheter Tray Recall
FDA (Devices) · 2013-06-12
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- High
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