On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min… recallZ-2133-2008 · I-Flow Corporation · initiated Feb 14, 2008
Terminated All recalls posted in September 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from I-Flow Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label.
FDA root cause category: Labeling design
What the company is doing
Firm faxed customer notification letters to customers on February 14, 2008 advising that two lots of CB005 (lot numbers 792457 and 7A2667) may contain an incorrect fill port label. All other product labeling is correct for the CB005 pumps. Customers are asked to inspect the CB005 inventory to determine if they have any of the affected lots. If so, customers are not to use the product and quarantine any remaining inventory. Customers are also asked to provide a copy of the notification to end users who may have received CB005, lot numbers 792457 and 7A2667. A response form is also provided.
Recall details
- Recall number
- Z-2133-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 14, 2008
- Posted by the FDA
- Sep 11, 2008
- Recalling firm
- I-Flow Corporation
- Quantity
- 792457 (430 units) and 7A2667 (390 units)
- Product code
- MEB
- FDA submissions
- K063530
- Distribution
- Class II Recall - Nationwide Distribution --- including states of IL, TX, PA, OK, NC, GA, MI, FL, OH, and CA.
Product description
On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites.
Code information (models, lots, serial numbers)
Lot Numbers: 792457 and 7A2667
Other devices under the same FDA submission
69 devices cleared under K063530 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ON-Q* Pain Relief System with SELECT-A-FLOW 13472Avanos Medical, Inc. · Pump, infusion, elastomeric73 reports
- Halyard 13472Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC68 reports
- ON-Q* Pain Relief System with SELECT-A-FLOW* 13476Avanos Medical, Inc. · Pump, infusion, elastomeric21 reports
- ON-Q* C-bloc with SELECT-A-FLOW* and ONDEMAND* 13474Avanos Medical, Inc. · Pump, infusion, elastomeric20 reports
- Halyard 13476Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC1 death19 reports
- Halyard 13685Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC19 reports
- Halyard 13477Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC1 death14 reports
- Halyard 13474Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC9 reports
- Halyard 13483Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC9 reports
- ON-Q* C-Bloc with SELECT-A-FLOW* and ONDEMAND* 13473Avanos Medical, Inc. · Pump, infusion, elastomeric6 reports
- ON-Q* Pain Relief System 13630Avanos Medical, Inc. · Pump, infusion, elastomeric6 reports
- Halyard 13473Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page