Device recall

Z-2393-2020: DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External…

FDA device recall · Class II · Defibtech, LLC

Key facts

Recall number (Z-number) Z-2393-2020
Recall event 85702
Product DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
Product code MKJ
Recalling firm Defibtech, LLC
Recall class Class II
Status Terminated
Termination date Jan 8, 2021
FEI number 3003521780

At a glance

  • None 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)