# FDA recall Z-2359-2020

> **Physio-Control, Inc.** · Class II · device recall initiated 2020-04-24.

## 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.

## Reason for recall

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

## Distribution

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.

## Key facts

- **Recall number:** Z-2359-2020
- **Recalling firm:** Physio-Control, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-24
- **Report date:** 2020-06-17
- **Termination date:** 2023-07-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Redmond, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2359-2020

## Citation

> AI Analytics. FDA recall Z-2359-2020. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-2359-2020. Source: US FDA. Licensed CC0.

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