FDA Device recall Z-2549-2019

Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758

FDA Device
Class II
terminated
Published 2019-10-02

On 2019-10-02 the FDA classified a Class II recall of Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758 by Philips North America, citing the recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for us….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2549-2019
Classification	Class II
Status	terminated
Initiated	2018-08-08
Published	2019-10-02
Last updated	2026-09-13 11:55 UTC
Company	Philips North America
Distribution	AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY

Product

Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758

Reason

The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the defibrillator An Infant/Child pad cartridge should not be used on an adult because it delivers lower energy (50 J vs 150 J) than the Adult pads cartridge and may therefore not be effective on an adult.

Identifiers

code_info	Model# M5072A; Lots #s Y070115-04 - Y011118-07;

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2549-2019%22

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