Device 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.
Z-2360-2020
Product summary
- Event
- Event 85173
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6732
- Official record key
device-enforcement:Z-2360-2020
Official wording
Reason: Packaging of infant child reduced energy electrodes was not properly sealed.
Code information: Electrodes manufactured between August 2017 through October 2019 that have not yet reached their expiration date
Distribution pattern: 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.
Derived failure modes
-
Unknown
Packaging of infant child reduced energy electrodes was not properly sealed.