Z-0134-2012

Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL...

Name: Z-0134-2012 Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL...
Creator: Baxter Healthcare Corp.
Published: 2011-08-26
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2011-08-26 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8064. The Flo-Gard Volumetric... on 2011-08-26. The reason FDA records is "The Flo-Gard infusion Pump was released to the customer with OOS values for the Air Sensor Calibrations with the Air in Tubing test". 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-0134-2012
Status: Terminated
Initiated: 2011-08-26
Posted: 2011-10-28
Terminated: 2011-10-31
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8064. The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intravenous infusion of fluids at user-selected rates.
Product code: FRN Pump, Infusion
Reason for recall: The Flo-Gard infusion Pump was released to the customer with OOS values for the Air Sensor Calibrations with the Air in Tubing test.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: A Baxter Healthcare technician initially notified the sole customer on August 26, 2011 of the defective product and requested that the product be quarantined. On September 14, 2011 a technician visited the site to correct the problem observed on the Flo-Gard Infusion Pump. All required tests were performed and the results were found acceptable.
Quantity in commerce: 1 unit
Distribution: Distributed only in Puerto Rico.
Product codes and lots: product code 2M8064, serial number 8110057FB

Product code FRN

K915523Class IIFlo-Gard(r) 6301Baxter Healthcare Corp / cleared 1992-02-28

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)