RecallDepth

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.

Company
Baxter Healthcare Corp. Rt
Recall Initiated
August 26, 2011
Posted
October 28, 2011
Terminated
October 31, 2011
Recall Number
Z-0134-2012
Quantity
1 unit
Firm Location
Round Lake, IL

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.

Distribution

Distributed only in Puerto Rico.

Lot / Code Info

product code 2M8064, serial number 8110057FB

Root Cause

Employee error

Action Taken

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.

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