RecallDepth

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.

Company
Baxter Healthcare Corp. Rt
Recall Initiated
March 24, 2011
Posted
April 29, 2011
Terminated
April 29, 2011
Recall Number
Z-2122-2011
Quantity
3 units
Firm Location
Round Lake, IL

Reason for Recall

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

Distribution

Puerto Rico

Lot / Code Info

Serial numbers 6100410FA, 8110687FA and 11021746FA

Root Cause

Employee error

Action Taken

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.

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