Z-0358-2007

I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742

Name: Z-0358-2007 I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742
Creator: I-Flow Corporation
Published: 2006-11-29
License: https://open.fda.gov/license/

Halyard Health / initiated 2006-11-29 / Terminated / root cause: labeling and UDI

FDA source

I-Flow Corporation began a recall of I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742 on 2006-11-29. The reason FDA records is "The pump flow rate labeling may not match the package labeling. The label on filter may not match the label on the top of the pump or the package labeling". 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-0358-2007
Status: Terminated
Initiated: 2006-11-29
Posted: 2007-01-18
Terminated: 2009-12-11
Recalling firm: Halyard Health
Product: I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742
Product code: MEB Pump, Infusion, Elastomeric
Reason for recall: The pump flow rate labeling may not match the package labeling. The label on filter may not match the label on the top of the pump or the package labeling.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A Recall Notification Letter was faxed to affected customers on November 29, 2006. Affected customers were notified of the identity of product subject to recall, the reason for recall, and instructed to quarantine immediately any remaining inventory. A Customer Response (FAX back) form was included with the Recall Notification Letter (dated November 29, 2006). Affected customers were requested to return the FAX back form to I-Flow within 48 hours of receipt. The fax back form indicates the quantity of remaining product from each lot the customer may have.
Quantity in commerce: 3475
Distribution: Nationwide
Product codes and lots: Lot numbers: 662449 & 662742

Product code MEB

K932740Class IIHomepump NsfBlock Medical, Inc. / cleared 1993-10-06

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)