Device recall

Z-0610-2020: Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight…

FDA device recall · Class I · Smiths Medical ASD Inc.

Key facts

Recall number (Z-number) Z-0610-2020
Recall event 84232
Product Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
Product code FRN
Recalling firm Smiths Medical ASD Inc.
Recall class Class I
Status Terminated
Termination date Jun 6, 2024
510(k) numbers K111386
FEI number 3012307300

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

Browse all FDA device recalls (products)