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.
This recall has been terminated (originally issued September 11, 2008).
- Company
- I-Flow Corporation
- Recall Initiated
- February 14, 2008
- Posted
- September 11, 2008
- Terminated
- October 7, 2009
- Recall Number
- Z-2133-2008
- Quantity
- 792457 (430 units) and 7A2667 (390 units)
- Firm Location
- Lake Forest, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label.
Distribution
Class II Recall - Nationwide Distribution --- including states of IL, TX, PA, OK, NC, GA, MI, FL, OH, and CA.
Lot / Code Info
Lot Numbers: 792457 and 7A2667
Root Cause
Labeling design
Action Taken
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.