FDA Medical Device Recalls (openFDA)
I-Flow Corporation: 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.
- Recall number
- Z-2133-2008
- Recalling firm
- I-Flow Corporation
- Product
- 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.
- Status
- Terminated
- Initiated
- 2008-02-14
- Posted
- 2008-09-11
- Terminated
- 2009-10-07
- Reason
- Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label.
- Root cause
- Labeling design
- Action
- 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.
- Quantity
- 792457 (430 units) and 7A2667 (390 units)
- Distribution
- Class II Recall - Nationwide Distribution --- including states of IL, TX, PA, OK, NC, GA, MI, FL, OH, and CA.
- Lot, serial or model codes
- Lot Numbers: 792457 and 7A2667
- 510(k) numbers
- ["K063530"]
- PMA numbers
- not on file
- Product code
- MEB
- Firm FEI
- 3011270181
- Firm city
- Lake Forest
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28