FDA recall Z-2549-2019

Product

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

Reason for recall

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.

Distribution

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,

Key facts

Status

Terminated

Initiation date

2018-08-08

Report date

2019-10-02

Termination date

2021-04-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bothell, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2549-2019