China NMPA Product Recall - Absorbable Surgical Suture with Needle

The National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated by B. Braun Surgical SA (Spain) on June 20, 2022. This action was prompted by the registrant's discovery that certain batches of their Absorbable Surgical Sutures with Needles (Registration Certificate No.: 20163024884) failed to meet specified degradation test requirements.

The core issue identified was a critical failure in the degradation performance of the product, indicating a potential compromise in its intended functionality and integrity over its shelf life. This finding led B. Braun Surgical SA, through its local entity B. Braun Medical (Shanghai) International Trading Co., Ltd., to promptly implement a voluntary recall to address the quality non-conformity.

This recall underscores the stringent regulatory oversight by the NMPA in ensuring medical device safety and efficacy within China. The Class II designation for this recall signifies a situation where 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. The company is required to manage the recall of affected product batches to mitigate potential risks to patient safety and ensure adherence to established quality standards.