I-Flow ON-Q Pain Relief System — Class II medical device recall Z-1445-2013
Terminated recall by I-Flow LLC, reported 2013-06-12, distributed nationwide. I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray a
| Recall number | Z-1445-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | I-Flow LLC, Lake Forest, CA, United States |
| Recall initiated | 2012-06-01 |
| Classified | 2013-06-03 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2013-06-25 |
| Distributed | Nationwide (US) |
| Quantity | 75 units |
| Reason classes | device malfunction |
| Lot numbers | AW207202U |
| Model numbers | TB089T |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1445-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.