Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-2359-2020

April 24, 2020

Class II

Product summary

Firm
Physio-Control, Inc.
Event
Event 85173
Status
Terminated
Classification
Class II
Quantity
118689
Official record key
device-enforcement:Z-2359-2020

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

    reason.no_named_rule · v1.0.0

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