Z-2122-2011

Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL...

Name: Z-2122-2011 Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL...
Creator: Baxter Healthcare Corp.
Published: 2011-03-24
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2011-03-24 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063 The Flo-Gard... on 2011-03-24. The reason FDA records is "Pumps submitted for service may not have been properly serviced before being returned to the customer". 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-2122-2011
Status: Terminated
Initiated: 2011-03-24
Posted: 2011-04-29
Terminated: 2011-04-29
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063 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: Pumps submitted for service may not have been properly serviced before being returned to the customer.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Baxter visited the direct accounts starting on 3/24/11 informing them that the affected Flo-Gard pumps may have been released from the preventative maintenance with incorrect accuracy testing. The affected pumps were located, taken out of service and placed in quarantine on the same date. A technician not involved with the previous testing visited both accounts on 3/25/11 and performed preventative maintenance service of the three affected devices, and were found to be within specification.
Quantity in commerce: 3 units
Distribution: Puerto Rico
Product codes and lots: Serial numbers 6100410FA, 8110687FA and 11021746FA

Product code FRN

K915522Class IIFlo-Gard(r) 6201Baxter 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)