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 Recall Z-2122-2011 · Posted 2011-04-29
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Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFRN
Date Initiated2011-03-24
Date Terminated2011-04-29
Product Quantity3 units
Reason for Recall
Pumps submitted for service may not have been properly serviced before being returned to the customer.
Firm Action
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.
Root Cause
Employee error
Distribution Pattern
Puerto Rico
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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