Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
Reported: October 2, 2019 Initiated: August 8, 2018 #Z-2549-2019
Product Description
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.
Details
- Recalling Firm
- Philips North America LLC
- Units Affected
- 181,894 Infant/Child SMART Pads Pads
- 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,
- Location
- Bothell, WA
Frequently Asked Questions
What product was recalled? ▼
Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758. Recalled by Philips North America LLC. Units affected: 181,894 Infant/Child SMART Pads Pads.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 2, 2019. Severity: Moderate. Recall number: Z-2549-2019.
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