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

Recalled June 17, 2020 · FDA recall Z-2360-2020 · Physio-Control

Hazard

Packaging of infant child reduced energy electrodes was not properly sealed. · FDA Class II

Units

6732

Sold at

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 countries of CA, ZA, TW, AU, JP, HK, MA, NZ, SG, BR, NL, PA, SA, AR, CL, TH, SV, CR, TR, GU, MY, VI.

Description

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

Product

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.

Manufacturer(s)

Physio-Control, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →