Recall Z-2133-2008 ยท MEB Pump, Infusion, Elastomeric
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.
| Date | Sep 11, 2008 (initiated Feb 14, 2008) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063530 | ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP I-Flow Corp., Jan 26, 2007 |