Device recall

Z-0650-2010: Smiths Medical Medfusion model 3500 syringe Infusion pump, software version…

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

Key facts

Recall number (Z-number) Z-0650-2010
Recall event 53940
Product Smiths Medical Medfusion model 3500 syringe Infusion pump, software version V3.0.6. Model 3500. Rx Only. Smiths Medical MD, Inc., St. Paul, Minnesota 55112 (USA).
Product code FRN
Recalling firm Smiths Medical ASD, Inc.
Recall class Class II
Status Terminated
Termination date Dec 18, 2011
510(k) numbers K040899
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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