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FDAFebruary 4, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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