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 intermitte
FDA device recall Z-2133-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- I-Flow Corporation
- Reason for recall
- Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label.
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- MEB
- Quantity affected
- 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.
- Date initiated
- 2008-02-14
- Date posted
- 2008-09-11
- Date terminated
- 2009-10-07
- Location
- Lake Forest, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP (K063530) | I-Flow Corp. | 2007-01-26 |