FDAJuly 16, 2021device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

philips north americaphilipsphilips north

UPCs

00884838023758

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear