FDA-Device2019-10-02Class II
Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
Philips North America LLC
Hazard
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.
Sold states
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 Republic, Egypt, El Salvador, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Malta, Martinique, Mauritius, Mexico, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Norway, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, R¿union, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, United Kingdom, Uruguay, Viet Nam,
Affected count
181,894 Infant/Child SMART Pads Pads
Manufactured in
22100 Bothell Everett Hwy, Bothell, WA, United States
Products
Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2549-2019Don't want to check this manually?
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