medical Class II Updated 2021-09-15

Philips North America LLC recalls Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, RE

Recalled 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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Y111220-01
View official government recall

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