Physio-Control, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2360-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 24, 2020

Date Posted: June 17, 2020

Recall Number: Z-2360-2020

Event ID: 85173

Reason for Recall:

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

Status: Terminated

Product Quantity: 6732

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.

Voluntary or Mandated:

Voluntary: Firm initiated