China NMPA Product Recall - stretcher

Stryker Medical, through its Beijing subsidiary Stryker (Beijing) Medical Devices Co., Ltd., initiated a voluntary Class III recall of its Model 6100 stretcher carts. This action, reported to the National Medical Products Administration (NMPA) on July 4, 2017, stemmed from a manufacturing defect where the roller assembly in the stretcher's lifting mechanism was found to be 2mm longer than specified. This dimensional inaccuracy led to the red release lever mechanism, located at the head of the stretcher, becoming jammed by a Schnitzler safety hook. Consequently, the lever could remain continuously activated, causing the stretcher head to descend unexpectedly and rapidly from elevated positions, posing a potential safety risk to patients during transport. The issue was identified following customer complaints. While the recall specifically targets affected units in regions such as Australia and Germany, Stryker confirmed that no products with the identified defect were imported or sold within China. Therefore, the company stated no further corrective actions would be taken concerning the Chinese market. The "Medical Device Recall Event Report Form" detailing this issue was duly submitted to the relevant Provincial Food and Drug Administration Department as part of the regulatory framework.