CLASS II Device recall · Reported 12 Jun 2013 · FDA Enforcement Report
ON-Q Pain Relief System, T-Block Needle/Catheter Tray recalled by I-Flow
I-Flow is recalling I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, distributed nationwide in the US. The recall was initiated on 1 Jun 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1444-2013
- FDA event ID
- 64826
- Recalling firm
- I-Flow, Lake Forest, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jun 2012
- FDA classified
- 3 Jun 2013
- Reported
- 12 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 1 Jun 2012 | Recall initiated by company | |
| 3 Jun 2013 | Classified by FDA | +367 days |
| 12 Jun 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Nationwide distribution: USA including states of: CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.
Nationwide CaliforniaConnecticutFloridaIllinoisIndianaKentuckyNew YorkOhioOregonTennesseeTexasVirginiaWisconsin
Questions about this recall
Is ON-Q Pain Relief System, T-Block Needle/Catheter Tray recalled?
Yes. I-Flow recalled ON-Q Pain Relief System, T-Block Needle/Catheter Tray on 1 Jun 2012. The recall is Class II and its status is Terminated. Recall number Z-1444-2013.
Why was it recalled?
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.
Which lots are affected?
Lot # AW207202O
Where was it sold?
Nationwide distribution: USA including states of: CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from I-Flow
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ON-Q Pain Relief System, T-Block Needle/Catheter Kit recalled by I-Flow | I-Flow | Device Malfunction | Nationwide |
| Device | CLASS I | On-q pump with Ondemand bolus button, On-q C-bloc with Ondemand recalled | I-Flow | Device Malfunction | CA |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |