Philips North America LLC recalls Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758

Recall date

August 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2549-2019

FDA classification

Class II

Brand / firm

Philips North America LLC

Sold / distributed

US: 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, Argentina, Aruba, Australia, Austria, Belgium, Bolivia, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Denmark, Dominican Re…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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