China NMPA Product Recall - Tourniquet system

On November 18, 2019, the National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated by Stryker (Beijing) Medical Devices Co., Ltd., concerning specific tourniquet systems. These medical devices, manufactured by Cook Incorporated (Registration Certificate No.: "."), were identified with a critical defect: a loss of function attributed to air leakage within certain product batches. This malfunction directly compromises the operational integrity of the tourniquet systems, posing a potential risk to patients and healthcare professionals during their use.

The recall falls under the regulatory purview of the NMPA, which is responsible for ensuring the safety and efficacy of medical devices in China. The classification as a Class II recall indicates that the product defect could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. As a required action, Stryker has initiated a voluntary retrieval of the affected products. Comprehensive details regarding the precise models, specifications, and batch numbers involved in this recall are documented in the "Medical Device Recall Event Report Form," which is available as an attachment to the NMPA's public announcement. This proactive measure by Stryker and Cook Incorporated demonstrates adherence to regulatory frameworks and a commitment to maintaining high standards of product quality and patient safety.