Device recall

Z-1565-2023: Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System…

FDA device recall · Class I · ICU Medical Inc

Key facts

Recall number (Z-number) Z-1565-2023
Recall event 91874
Product Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
Product code FRN
Recalling firm ICU Medical Inc
Recall class Class I
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)