China NMPA Product Recall - Semi-automatic external defibrillator

Physio-Control, Inc. initiated a voluntary Class III recall for specific batches of its semi-automatic external defibrillators (NMPA Registration No. 20163212101). This recall, reported by its agent Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., on November 22, 2017, and published by the National Medical Products Administration (NMPA) on December 1, 2017, addresses a packaging discrepancy. The primary issue is an incorrect illustration on the packaging of low-energy infant defibrillator electrode pads, depicting an improper electrode placement for infants. Critically, the performance or function of the affected defibrillators and electrodes remains unimpaired, with the problem strictly limited to the misleading diagram. No adverse event reports or customer complaints have been received regarding this issue. Operating under the NMPA regulatory framework, the company's required actions include a comprehensive recall. This entails ceasing the use of the affected low-energy infant defibrillator electrodes and implementing procedures for their retrieval and destruction. The recall impacts models such as the low-energy infant defibrillator electrode 11101-000016, with 30 units in China bearing affected identification information like batch numbers 713609 and 717912. This global recall aims to prevent potential user errors due to the incorrect visual guidance, ensuring patient safety.