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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0881-2022
Event ID89672
Event DescriptionPhilips, REF M5071A, Adult. Smart PADS CARTRIDGE , 8+ years FOR USE WITH HEARSTART HS1 DEFIRIBRULATORS
Product TypeDevices
DistributionUS: 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
Quantity1,490,949 UNITS
Recall ReasonThere 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 Classification20220413
Device Code InfoALL LOTS
Center Classification Date20220406
Recall Initiation Date20220204
Recalling FirmPhilips North America LLC
Initial Notification Letter
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