On April 6, 2022 the FDA in conjunction with Phillips issued a Class 2 Device Recall for the PHILIPS ADULT SMART PADS CARTRIDGE. The recall was issued due to the potential for the AED pad gel to separate from the foam/tin backing when peeled from the plastic liner. During the peeling process, 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.
The FDA alert provides important information on actions organizations should take.
Please reach out to the C&A team with further questions or for assistance with your regulatory compliance needs.