Philips North America LLC Recall 89672
Description: Philips, REF M5071A, Adult. Smart PADS CARTRIDGE , 8+ years FOR USE WITH HEARSTART HS1 DEFIRIBRULATORS
Philips North America LLC Recall 89672 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0881-2022 |
Event ID | 89672 |
Event Description | Philips, REF M5071A, Adult. Smart PADS CARTRIDGE , 8+ years FOR USE WITH HEARSTART HS1 DEFIRIBRULATORS |
Product Type | Devices |
Distribution | US: Nation-wide OUS: 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 R¿union Luxembourg Qatar El Salvador Namibia Myanmar Nigeria Poland Aruba Greece Martinique Guadeloupe Dominican Republic China Kosovo Portugal Bangladesh Tanzania Peru Lithuania New Caledonia Palestine, State of Finland Cambodia Macao Cyprus Zambia Viet Nam Uruguay Ecuador Puerto Rico Netherlands Antilles Guam Czech Republic French Polynesia Kenya Cameroon Guinea Mayotte Brunei Darussalam |
Quantity | 1,490,949 UNITS |
Recall Reason | 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 sperate almost completely leaving only a small amount of gel on the pad. |
Device Classification | 20220413 |
Device Code Info | ALL LOTS |
Center Classification Date | 20220406 |
Recall Initiation Date | 20220204 |
Recalling Firm | Philips North America LLC |
Initial Notification | Letter |
Similar To |