Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
This recall has been terminated (originally issued August 8, 2018).
- Company
- Philips North America Llc
- Recall Initiated
- August 8, 2018
- Terminated
- April 29, 2021
- Recall Number
- Z-2549-2019
- Quantity
- 181,894 Infant/Child SMART Pads Pads
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
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,
Lot / Code Info
Model# M5072A; Lots #s Y070115-04 - Y011118-07;
Root Cause
Labeling False and Misleading
Action Taken
A labeling specification for the HS1 is available against which labeling can be checked prior to design transfer and/or localization. This activity has been moved under regulatory affairs for review and maintenance.