Recall record at a glance
| Official record | Z-0882-2022 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Philips North America LLC |
| Report date | Apr 13, 2022 |
| Recall initiation date | Feb 4, 2022 |
| Quantity | 331,712 UNITS |
| Location | Bothell, WA, United States |
Official product description
Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS
Why the product was recalled
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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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