# China NMPA Product Recall - Hole punch

Source: https://www.globalkeysolutions.net/records/china_product_recall/telif-medical-devices-trading-shanghai-co-ltd/c0190543-ab00-470a-88b5-d01781e3a394/
Source feed: China

> China NMPA product recall for Hole punch by Telif Medical Devices Trading (Shanghai) Co., Ltd. published February 03, 2020. Recall level: Level 2 Recall. Terif Medical Devices Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its hole

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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: 2020-02-03
- Product Name: Hole punch
- Recall Level: Level 2 Recall
- Recall Reason: Because the packaging of equipment involving model and batch numbers may be damaged, the sterility of the product cannot be guaranteed. Using a product with compromised sterility may lead to contamination and infection, potentially damaging anastomoses 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 of its hole punch devices, as announced by the National Medical Products Administration (NMPA) on February 3, 2020. The recall stems from concerns regarding potential damage to the packaging of specific models and batches of the devices. This packaging integrity issue compromises the sterility of the product, creating a risk of contamination and infection for patients. Such infections could potentially lead to serious complications, including damage to anastomoses and wound infections. While no complaints, patient injuries, or fatalities have been reported to date, Terif Medical Devices is undertaking this proactive measure to safeguard patient safety. The recall, detailed in the "Medical Device Recall Event Report Form," aims to mitigate the risk associated with compromised sterile products. The NMPA oversees this regulatory action, ensuring that affected devices are removed from circulation to prevent potential adverse health consequences. This action underscores the company's commitment to product quality and patient well-being under the NMPA's regulatory oversight.

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