# China NMPA Product Recall - Hole punch

Source: https://www.keypedia.com/records/china_product_recall/telif-medical-devices-trading-shanghai-co-ltd/63db82a8-e0be-4a0a-a736-ab185fb13c3f
Source feed: China

> China NMPA product recall for Hole punch by Telif Medical Devices Trading (Shanghai) Co., Ltd. published March 05, 2020. Recall level: Level 2 Recall. Terif Medical Devices Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Hol

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Terifor Medical Devices Trading (Shanghai) Co., Ltd. has initiated a voluntary recall of hole punchers.
- Company Name: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-03-05
- Product Name: Hole punch
- Recall Level: Level 2 Recall
- Recall Reason: The equipment packaging may be damaged; therefore, the sterility of the product cannot be guaranteed. Using a product with compromised sterility may lead to contamination and infection, potentially damaging the anastomosis and causing wound infection.
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Summary: Terif Medical Devices Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Hole Punch Devices (Registration Certificate No.: 20192030085). The recall, initially reported on February 3, 2020, and updated by the Shanghai Food and Drug Administration on February 4, 2020, addresses a critical product defect. The primary concern stems from potential damage to the equipment packaging, which compromises the sterility of the devices. This compromised sterility presents a significant health risk, potentially leading to contamination, infection, damage to anastomoses, and wound infections in patients. Fortunately, the company has not received any reports of complaints, patient injuries, or deaths related to this issue. In an update, the company identified an additional 198 affected products in its warehouse's waiting area, which have since been isolated. This discovery revised the total number of affected products imported into China to 1302, with 641 units currently in the company's warehouse inventory. The National Medical Products Administration (NMPA) publicly announced this recall on March 5, 2020, highlighting the regulatory oversight provided by both the NMPA and the Shanghai Municipal Drug Administration. Terif Medical Devices Trading (Shanghai) Co., Ltd. is actively managing the recall to mitigate potential risks associated with the non-sterile devices.

Company: https://www.keypedia.com/companies/telif-medical-devices-trading-shanghai-co-ltd/c0fdb740-6e25-4782-94b0-a6f732669ee5