—#99440

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K915522
Affected lot / code info: Serial numbers 6100410FA, 8110687FA and 11021746FA

Why it was recalled

Pumps submitted for service may not have been properly serviced before being returned to the customer.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Puerto Rico

Timeline

Recall initiated: 2011-03-24
Posted by FDA: 2011-04-29
Terminated: 2011-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99440. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.