Z-2860-2011

I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to...

Name: Z-2860-2011 I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to...
Creator: I-Flow Corporation
Published: 2011-04-15
License: https://open.fda.gov/license/

Halyard Health / initiated 2011-04-15 / Terminated / root cause: manufacturing process

FDA source

I-Flow Corporation began a recall of I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close... on 2011-04-15. The reason FDA records is "The recall was initiated because I Flow became aware that a small percentage of ON-Q Pump with Select A Flow may develop a minor leak with a flow rate controller. There may be consequences for the patient, such as under...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2860-2011
Status: Terminated
Initiated: 2011-04-15
Posted: 2011-07-28
Terminated: 2012-08-09
Recalling firm: Halyard Health
Product: I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. It is a controller that allows the user to regulate the amount of medication that is dispensed.
Product code: MEB Pump, Infusion, Elastomeric
Reason for recall: The recall was initiated because I Flow became aware that a small percentage of ON-Q Pump with Select A Flow may develop a minor leak with a flow rate controller. There may be consequences for the patient, such as under delivery of pain medication or the need to prematurely remove the pump, which would result in loss of the pain treatment provided by the pump.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: I-Flow Corporation sent an "Important Voluntary Market Withdrawal Notice" dated May 12, 2011 to all affected customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to quarantine and return all impacted products within their facilities. Customers were instructed to respond with in 5 days of receiving the Market Withdrawal Notice and fax it to (949) 206-2663. Customers with additional questions, were instructed to call I-Flow Customer service at (800) 448-3569 (8-5pm, Pacific Standard time) or I-Flow 24 hour technical support line (800) 444-2728.
Quantity in commerce: 96,892 units total (95,637 units in US)
Distribution: Nationwide (USA) Distribution and worldwide to: Australia, Canada, Cyprus, Italy, Germany, Finland, Greece, Israel, South Africa, Sweden, UAE, and UK.
Product codes and lots: Model Numbers: CB004, CB005, CB006, CB6004, CB6007, P100X2-14, P200X2-14, P270X1-7, P400X2-14, P400X1-7+5/60, P400X2-14+5/30, P600X2-14, P600X1-7D, and SAF01. Part Numbers: 5001481,5001521,5001651,5001771,5001780,5001788,5001799, 5001807,5001808,5001809,5001810,5001811,5001830, and 5001831. Specific lot numbers: 122215, 132435, 132464, 932165, and 962434. Also, all lot numbers that begin with: 98 (except 982631 and 982645), 99, 9A (except 9A2913), 9B, 9C, 01, 02, 03, 04, 05, 06, 07, 08, 09, 0A, 0B, and 0C (except 0C2949 and 0C2950).

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)