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.
Thanks for releasing this information I have adult and pediatric pads that expired March 2022. Are there any other pads that can be substituted to keep us in compliance? Please advise, thanks.
Hi Lavonda. Thanks for your comment. I am forwarding your question to our consulting team and will get the information you are requesting as soon as possible. Thanks. Amy.
Hi Team, can we find out if there is a replacement available yet please as I need to purchase the next ones for my machine.