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.
FDA Recall Z-2133-2008 · Posted 2008-09-11
Recalling FirmI-Flow Corporation
Recall StatusTerminated
Product CodeMEB
Date Initiated2008-02-14
Date Terminated2009-10-07
Product Quantity792457 (430 units) and 7A2667 (390 units)
Reason for Recall
Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label.
Firm 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.
Root Cause
Labeling design
Distribution Pattern
Class II Recall - Nationwide Distribution --- including states of IL, TX, PA, OK, NC, GA, MI, FL, OH, and CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.