Device recall

Z-1542-2024: Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion…

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

Key facts

Recall number (Z-number) Z-1542-2024
Recall event 93771
Product Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E
Product code FRN
Recalling firm Smiths Medical ASD Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K040899
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)