# FDA recall Z-2427-2021

> **Philips North America LLC** · Class II · device recall initiated 2021-07-16.

## Product

Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator

## Reason for recall

Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient

## Distribution

Worldwide distribution. US Nationwide, Australia, Austria, Bolivia, Canada, Chile, China, Denmark, France, French Polynesia, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Republic of Korea, Malta, Martinique, Mexico, Monaco, Netherlands, Norway, Poland, Spain, Switzerland, Taiwan, United Kingdom, and Uruguay

## Key facts

- **Recall number:** Z-2427-2021
- **Recalling firm:** Philips North America LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-16
- **Report date:** 2021-09-15
- **Termination date:** 2023-05-12

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2427-2021

## Citation

> AI Analytics. FDA recall Z-2427-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2427-2021. Source: US FDA. Licensed CC0.

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