# China NMPA Product Recall - pneumoperitoneum machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/w-o-m-world-of-medicine-gmbh/aecf15eb-4a33-4f44-9449-08d582dda70f/
Source feed: China

> China NMPA product recall for pneumoperitoneum machine by W. O. M. World Of Medicine GmbH published April 22, 2016. Recall level: . W.O.M. World Of Medicine GmbH initiated a voluntary global recall of its insufflator (Registration C

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: W.O.M.World Of Medicine GmbH recalls insufflator.
- Company Name: W. O. M. World Of Medicine GmbH
- Publication Date: 2016-04-22
- Product Name: pneumoperitoneum machine
- Recall Reason: When the insufflator is connected to the operating room's central carbon dioxide gas supply, the inflation flow rate must not be set to exceed 18 L/min. When a malfunction occurs, a "Check gas supply" error message will appear. The insufflator will then pause inflation, causing a drop in intra-abdominal pressure.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: W. O. M. World Of Medicine GmbH
- Summary: W.O.M. World Of Medicine GmbH initiated a voluntary global recall of its insufflator (Registration Certificate No.: 20162540030) in April 2016, a situation reported by its Chinese distributor, Stryker (Beijing) Medical Devices Co., Ltd. The primary issue involves the device's inability to set the inflation flow rate above 18 L/min when connected to a central CO2 supply. This malfunction triggers an "Insufficient air supply" or "Check Gas Supply" error message, causing the insufflator to pause inflation and resulting in a critical drop in intra-abdominal pressure during diagnostic and therapeutic laparoscopic procedures. Under the regulatory oversight of the National Medical Products Administration (NMPA) of China, this recall was reported to ensure transparency, although the affected product was confirmed not to have been sold or imported into the Chinese market. Consequently, Stryker (Beijing) Medical Devices Co., Ltd. has not taken further direct action in China beyond reporting. However, the NMPA requested that provincial Food and Drug Administrations enhance supervision and management of similar medical devices. The recall affects multiple countries across Australia, North America, South America, Europe, Asia, and Africa, encompassing various models and serial numbers.

Company: https://www.globalkeysolutions.net/companies/w-o-m-world-of-medicine-gmbh/d734a660-aec9-4ba0-82ab-1f2982125e35/