Device recall

Z-2122-2011: Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare…

FDA device recall · Class II · Baxter Healthcare Corp.

Key facts

Recall number (Z-number) Z-2122-2011
Recall event 58482
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.
Product code FRN
Recalling firm Baxter Healthcare Corp.
Recall class Class II
Status Terminated
Termination date Apr 29, 2011
510(k) numbers K915522
FEI number 1416980

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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