Recall Z-2359-2020— Physio-Control, Inc.

Name: FDA recall Z-2359-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-24

Class II · Terminated

Class II FDA medical device recall by Physio-Control, Inc., initiated 2020-04-24, terminated 2023-07-27. It names one FDA 510(k) clearance: K022732. Product: Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation and in basic life support or other physician-authorized emergency medical response system.. Reason: Packaging of infant child reduced energy electrodes was not properly sealed..

Recalling firm: Physio-Control, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-04-24
Terminated: 2023-07-27
Firm location: Redmond, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K022732 — INFANT/CHILD REDUCED ENERGY ELECTRODESMedtronic Physio-Control Corp.·cleared 2002-12-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation and in basic life support or other physician-authorized emergency medical response system.

Reason for recall

Packaging of infant child reduced energy electrodes was not properly sealed.

Data sourced from openFDA. This site is unofficial and independent of the FDA.