China NMPA Product Recall - Embryo transfer catheter

The National Medical Products Administration (NMPA) reported on October 17, 2019, a voluntary Class II recall initiated by Cook Incorporated, a medical device manufacturer. This recall was officially reported by Cook (China) Medical Trading Co., Ltd. The affected products are specific batches of embryo transfer catheters, identified by Registration Certificate No.: 20192181618. The primary issue prompting this recall is a significant probability of a critical device malfunction. Specifically, the inner tube of the catheter is prone to bending at the tip, which subsequently obstructs its passage through the outer tube. This defect poses a concern for healthcare professionals and patients, as it could impede the intended use of the device during medical procedures. Under the regulatory oversight of the NMPA, the company initiated this voluntary action to address the safety and performance concerns. A Class II recall signifies that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Cook Incorporated is expected to provide comprehensive details regarding the specific models, specifications, and affected product batches in a "Medical Device Recall List" and a "Medical Device Recall Event Report Form" to facilitate the efficient retrieval and management of the faulty devices from the market.