Device recall

Z-0768-2007: Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software…

FDA device recall · Class II · Smiths Medical MD, Inc.

Key facts

Recall number (Z-number) Z-0768-2007
Recall event 37590
Product Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4. Medex, 4350 Green Parkway, Suite 200. Duluth, GA 30096
Product code FRN
Recalling firm Smiths Medical MD, Inc.
Recall class Class II
Status Terminated
Termination date Feb 10, 2011
510(k) numbers K982640
FEI number 2183502

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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