Device recall

Z-1309-2021: BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module…

FDA device recall · Class I · CareFusion 303, Inc.

Key facts

Recall number (Z-number) Z-1309-2021
Recall event 87387
Product BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
Product code FRN
Recalling firm CareFusion 303, Inc.
Recall class Class I
Status Open, Classified
510(k) numbers K133532
FEI number 2016493

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)