China NMPA Product Recall - stretcher

Stryker Medical, through its agent Stryker (Beijing) Medical Devices Co., Ltd., initiated a voluntary Class III recall of its Model 6100 stretcher carts, as reported on May 10, 2017, and published by the National Medical Products Administration (NMPA) on June 13, 2017. The recall was prompted by customer complaints revealing a critical safety issue: an excessively long roller assembly in the stretcher's lifting mechanism. This manufacturing deviation, specifically a 2mm longer component, causes the red release lever at the front of the stretcher to become jammed by a Schnitzler safety hook. Consequently, the lever remains continuously activated, leading to the unexpected and rapid descent of the stretcher front from a high position, posing a potential hazard to patients during transport. Operating under the NMPA's regulatory framework, Stryker submitted a Medical Device Recall Event Report Form detailing the issue and affected serial numbers (ST013-3578 to ST013-3767). While the recall notification identifies Australia and Germany as affected regions, the company confirmed that zero units of the affected stretcher carts were sold in China. The required action involves the voluntary recall of these specific units, with the company reporting the corrective measures to the relevant provincial Food and Drug Administration Department, ensuring accountability and compliance with medical device regulations.