Device recall

Z-0540-2014: Medfusion 4000 Syringe Infusion Pumps Medfusion 4000 Syringe Infusion Pumps are…

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

Key facts

Recall number (Z-number) Z-0540-2014
Recall event 66987
Product Medfusion 4000 Syringe Infusion Pumps Medfusion 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug…
Product code FRN
Recalling firm Smiths Medical ASD, Inc.
Recall class Class II
Status Terminated
Termination date Mar 25, 2015
510(k) numbers K111386
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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