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Philips North America LLC recalls Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
Recalled April 13, 2022 · FDA recall Z-0881-2022 · Philips North America
Hazard
There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad. · FDA Class II
Units
1,696,047
Sold at
Worldwide distribution. US Nationwide including Puerto Rico and Guam, Germany, Australia, Sweden, Japan, Canada, Taiwan, France, Netherlands, Spain, Singapore, Austria, South Africa, Italy, United Kingdom, India, Malaysia, Switzerland, Chile, Ireland, Norway, Hong Kong, Argentina, Mexico, Bolivia, Croatia, French Guiana, Denmark, United Arab Emirates, Hungary, Belgium, Indonesia, Korea, Republic of, Bhutan, New Zealand, Bulgaria, Mauritius, Trinidad and Tobago, Israel, Guatemala, Mali, Algeria, Philippines, Malta, Curacao, Panama, Paraguay, Costa Rica, Colombia, Liechtenstein, Saudi Arabia, Monaco, Estonia, Senegal, Reunion, Luxembourg, Qatar, El Salvador, Namibia, Myanmar, Nigeria, Poland, Aruba, Greece, Martinique, Guadeloupe, Dominican Republic, China, Kosovo, Portugal, Bangladesh, Tanzania, Peru, Lithuania, New Caledonia, State of Palestine, Finland, Cambodia, Macao, Cyprus, Zambia, Viet Nam, Uruguay, Ecuador, Netherlands Antilles, Czech Republic, French Polynesia, Kenya, Cameroon, Guinea, Mayotte, and Brunei Darussalam.
Description
There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad.
Product
Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
Manufacturer(s)
Philips North America LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →