China NMPA Product Recall - Absorbable Surgical Suture with Needle

B.Braun Surgical SA initiated a voluntary Class II recall of specific models and batches of its Absorbable Surgical Sutures with Needles. This action, reported by B.Braun Medical (Shanghai) International Trading Co., Ltd. on November 8, 2021, was prompted by a critical issue where degradation test results for these products failed to meet established quality standards. The affected medical devices, registered under certificate number 20163654884, were found to deviate from required performance specifications concerning their degradation properties. The recall operates under the regulatory oversight of the National Medical Products Administration (NMPA) of China, which governs medical device safety and compliance within the country. A Class II recall signifies that the product's use may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. As a result, B.Braun Surgical SA is required to remove the identified non-compliant batches from distribution and use. Healthcare facilities and distributors in possession of the affected absorbable surgical sutures with needles are instructed to follow the recall procedures detailed in the "Medical Device Recall List" and the "Medical Device Recall Event Report Form" provided by the company. This action underscores the company's commitment to product quality and patient safety in adherence to NMPA regulations.