# China NMPA Product Recall - Laparoscopic gastric volume adjustment band

Source: https://www.globalkeysolutions.net/records/china_product_recall/obtech-medical-sarl/395c5a3f-c773-4a05-8af1-bb12026e3474/
Source feed: China

> China NMPA product recall for Laparoscopic gastric volume adjustment band by Obtech Medical Sarl published November 03, 2010. Recall level: . This document from the National Medical Products Administration (NMPA) details a medical device reca

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Recall Event Report Form for Laparoscopic Gastric Volume Adjustment Band
- Company Name: Obtech Medical Sarl
- Publication Date: 2010-11-03
- Product Name: Laparoscopic gastric volume adjustment band
- Recall Reason: This product recall was initiated because Obtech Medical Sarl Ethicon-Endo Surgery recently received a report that the tension-reducing hose component on the SAGB Velocity™ injection pump had detached from the locking connector and could potentially leave its original position on the locking connector.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Obtech Medical Sarl
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/obtech-medical-sarl/de6eee67-fdca-4543-b436-3ff1691505e7/