FDA-Device2020-06-17Class II
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.
Physio-Control, Inc.
Hazard
Packaging of infant child reduced energy electrodes was not properly sealed.
Sold states
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.
Affected count
118689
Manufactured in
11811 Willows Rd Ne, N/A, Redmond, WA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2359-2020Don't want to check this manually?
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