—#104641

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K915523
Affected lot / code info: product code 2M8064, serial number 8110057FB

Why it was recalled

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 (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Distributed only in Puerto Rico.

Timeline

Recall initiated: 2011-08-26
Posted by FDA: 2011-10-28
Terminated: 2011-10-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104641. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.