Device recall

Z-2430-2023: Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413…

FDA device recall · Class II · ICU Medical Inc

Key facts

Recall number (Z-number) Z-2430-2023
Recall event 92630
Product Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 300101013, 300101113, 300101114, 300101313, 300101379, 300102213, 300102713, 300102913, 300103413, 300103414, 300104213…
Product code FRN
Recalling firm ICU Medical Inc
Recall class Class II
Status Open, Classified
510(k) numbers K141789, K161469
FEI number 3013319212

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)