China NMPA Product Recall - Laparoscopic gastric volume adjustment band

This document from the National Medical Products Administration (NMPA) details a medical device recall initiated by Obtech Medical Sarl, with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. acting as the responsible unit in China. The recall, reported on October 12, 2010, and published on November 3, 2010, concerns the Laparoscopic Gastric Volume Adjustment Band, specifically the SAGB Velocity™ infusion pump (models BD2XV, BD3XV, PT2XV). The primary issue identified is the potential detachment of the tension-reducing tubing component from its locking connector, which could lead to its displacement. Based on sales data from 2005, the manufacturer estimated the probability of tubing component slipping at 0.06%, with a less than 0.01% chance of tubing folding. The regulatory framework for this recall falls under the NMPA's medical device recall guidelines for imported products. Significantly, the manufacturer assessed that this issue is "unlikely to cause serious harm or adverse health consequences" to patients, and therefore, implanted devices do not require removal. The mandated corrective action is to notify all users of the affected products about the potential issue. A total of 144 units were imported into China, with 74 sold and 70 remaining in inventory.