Device recall

Z-0745-2022: HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with…

FDA device recall · Class III · Physio-Control, Inc.

Key facts

Recall number (Z-number) Z-0745-2022
Recall event 89536
Product HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Product code MKJ
Recalling firm Physio-Control, Inc.
Recall class Class III
Status Terminated
Termination date May 19, 2023
PMA numbers P160008
FEI number 3015876

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)