Physio-Control, Inc. recalls Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes,…

Recall date

April 24, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2360-2020

FDA classification

Class II

Brand / firm

Physio-Control, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of NY,TX, IL, CO, TN, MI, FL, CT, GA, WA, AZ, NJ, MA, MO, NC, MD, OH, PA, CA, IA, VA, WI, MN, SC, IN, DE, KY, MT, AL, MS, NM, ME, OK, WV, SD, RI, ND, LA, AR, HI, DC, KS, NE, VT, OR, AK, NV, UT, WY, NH, PR, ID, and the count…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, 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.