Device recall

Z-0186-2018: LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006…

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

Key facts

Recall number (Z-number) Z-0186-2018
Recall event 78303
Product LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
Product code MKJ
Recalling firm Physio-Control, Inc.
Recall class Class I
Status Terminated
Termination date Jun 12, 2019
510(k) numbers K022732
FEI number 3015876

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

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