Physio-Control, Inc. is recalling its Infant/Child Reduced Energy Defibrillator Electrodes (Catalog Numbers: 11101-000016, 11101-000017) due to delamination of the pediatric defibrillator electrodes. This recall is classified as Class II by the FDA, signifying that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The affected products were distributed worldwide, including nationwide across the United States.

Medical device manufacturers and healthcare providers should be aware of this recall and take immediate steps to identify and remove affected products from inventory and patient use. Compliance officers should review their internal procedures for handling device recalls and ensure adherence to FDA guidelines. While specific compliance deadlines are not detailed in this notice, prompt action is expected to mitigate potential patient harm and ensure regulatory compliance. Failure to comply with recall procedures can result in further regulatory action.