Z-2133-2008

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...

Name: Z-2133-2008 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...
Creator: I-Flow Corporation
Published: 2008-02-14
License: https://open.fda.gov/license/

Halyard Health / initiated 2008-02-14 / Terminated / root cause: labeling and UDI

FDA source

I-Flow Corporation began a recall of 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... on 2008-02-14. The reason FDA records is "Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2133-2008
Status: Terminated
Initiated: 2008-02-14
Posted: 2008-09-11
Terminated: 2009-10-07
Recalling firm: Halyard Health
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.
Product code: MEB Pump, Infusion, Elastomeric
Reason for recall: Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Lot Numbers: 792457 and 7A2667

Product code MEB

K063530Class IIOn-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step Kvo, EasypumpI-Flow Corp. / cleared 2007-01-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)