Recall Z-0882-2022— Philips North America LLC
Class II · Ongoing
Class II FDA medical device recall by Philips North America LLC, initiated 2022-02-04. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. 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 separate almost completely leaving only a small amount of gel on the pad..
- Recalling firm
- Philips North America LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-02-04
- Firm location
- Bothell, WA, United States
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.