# China NMPA Product Recall - Basix Touch Inflation Device - Inflation Pump System

Source: https://www.globalkeysolutions.net/records/china_product_recall/merit-medical-system-inc/3d45842f-d4b3-4674-b87d-25929d803579/
Source feed: China

> China NMPA product recall for Basix Touch Inflation Device - Inflation Pump System by Merit Medical System, Inc published April 12, 2022. Recall level: Level 2 Recall. Merit Medical Systems, Inc. initiated a voluntary recall of specific models and batches of its Basix

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Merit Medical Systems, Inc. is proactively recalling its Basix Touch Inflation Device filling pressure pump system.
- Company Name: Merit Medical System, Inc
- Publication Date: 2022-04-12
- Product Name: Basix Touch Inflation Device - Inflation Pump System
- Recall Level: Level 2 Recall
- Recall Reason: After the product design change, there is an internal gap between the rotary valve body and the Y-valve body of the hemostatic valve, which may cause the guidewire to get stuck, making guidewire advancement difficult.
- Discovering Company: Mairuitong Medical Devices (Beijing) Co., Ltd.
- Manufacturing Company: Merit Medical System, Inc
- Summary: Merit Medical Systems, Inc. initiated a voluntary recall of specific models and batches of its Basix Touch Inflation Device, as announced by the National Medical Products Administration (NMPA) on April 12, 2022. The recall was prompted by a design change that created an internal gap within the rotary Y-valve body of the hemostatic valve. This critical issue could impede the advancement of guidewires, potentially affecting patient procedures and safety. Merit Medical Devices (Beijing) Co., Ltd. reported the issue, leading to the manufacturer, Merit Medical Systems, Inc., taking action. The recall, whose specific level was not detailed, falls under the regulatory oversight of the NMPA. The required action involves the voluntary recall of the affected devices (Registration Certificate No.: 20183662068), with detailed information on specific models, specifications, and batches provided in an attached Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/merit-medical-system-inc/bdb3b241-bddf-403c-a1ee-17b7dedba8b4/