FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: 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.
- Recall number
- Z-0134-2012
- Recalling firm
- Baxter Healthcare Corp.
- 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.
- Status
- Terminated
- Initiated
- 2011-08-26
- Posted
- 2011-10-28
- Terminated
- 2011-10-31
- Reason
- 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
- 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
- 1 unit
- Distribution
- Distributed only in Puerto Rico.
- Lot, serial or model codes
- product code 2M8064, serial number 8110057FB
- 510(k) numbers
- ["K915523"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1416980
- Firm city
- Round Lake
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28