China NMPA Product Recall - Semi-automatic external defibrillator

Physio-Control, Inc., in collaboration with its agent Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., initiated a voluntary recall of specific batches of its semi-automatic external defibrillators. This action, reported to the National Medical Products Administration (NMPA) on November 22, 2017, addresses a critical labeling error. The primary issue concerns an incorrect illustration on the packaging of certain low-energy infant defibrillator electrode pads, depicting an improper electrode placement for infants. While the functionality and performance of the defibrillator electrodes remain unaffected, this graphic inaccuracy could lead to misuse. The recall is classified as Class III by NMPA and a global Level Two, indicating a remote probability of adverse health consequences. Under NMPA guidance, required actions include the immediate cessation of use of affected low-energy infant defibrillator electrodes (Model: 11101-000016, Batch numbers: 713609, 717912). Additionally, customers are instructed to retrieve and ensure the destruction of all unused affected electrodes to prevent potential user error stemming from the mislabeled instructions. This recall impacts 30 units manufactured or imported into China, with 5 already sold in the region.