Device recall

Z-1544-2026: PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog…

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

Key facts

Recall number (Z-number) Z-1544-2026
Recall event 98257
Product PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow…
Product code MKJ
Recalling firm Physio-Control, Inc.
Recall class Class II
Status Open, Classified
PMA numbers P160012
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)