# China NMPA Product Recall - Abdominal trocar

Source: https://www.globalkeysolutions.net/records/china_product_recall/hangzhou-tonglu-yida-medical-equipment-co-ltd/64f8432b-3b71-4336-b1f0-8b6ce004961b/
Source feed: China

> China NMPA product recall for Abdominal trocar by Hangzhou Tonglu Yida Medical Equipment Co., Ltd. published January 17, 2019. Recall level: Level 3 Recall. Hangzhou Tonglu Yida Medical Device Equipment Co., Ltd. initiated a voluntary Class III recall of it

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Hangzhou Tonglu Yida Medical Instrument Equipment Co., Ltd. voluntarily recalls abdominal trocars.
- Company Name: Hangzhou Tonglu Yida Medical Equipment Co., Ltd.
- Publication Date: 2019-01-17
- Product Name: Abdominal trocar
- Recall Level: Level 3 Recall
- Recall Reason: The maximum mating clearance between the puncture cannula and the puncture needle failed the national medical device supervision and spot check.
- Discovering Company: Hangzhou Tonglu Yida Medical Equipment Co., Ltd.
- Manufacturing Company: Hangzhou Tonglu Yida Medical Equipment Co., Ltd.
- Summary: Hangzhou Tonglu Yida Medical Device Equipment Co., Ltd. initiated a voluntary Class III recall of its Abdominal Puncture Devices (Registration Certificate No.: Zhexiezhuzhun 20172220107), as announced by the National Medical Products Administration (NMPA) on January 17, 2019. The recall stemmed from a non-compliance identified during a national medical device supervision and spot check. The main issue was that the product failed to meet the specified standard for the maximum mating clearance between the puncture cannula and the puncture needle, which should not exceed 0.3mm. The affected products belong to model YDCC/5.5 × 95, batch number 18051710. A total of 20 units were produced in this specific batch. The regulatory framework under which this issue was identified is the NMPA's national medical device supervision. As required actions, Hangzhou Tonglu Yida Medical Device Equipment Co., Ltd. verified the production quantity of the non-compliant batch. Importantly, all 20 units from this batch were subject to state sampling and, consequently, none of them entered the market or were sold to consumers. The non-compliant samples were not returned to the manufacturer but were instead destroyed by the Shanghai Medical Device Inspection Institute, ensuring public safety and preventing distribution of the defective devices.

Company: https://www.globalkeysolutions.net/companies/hangzhou-tonglu-yida-medical-equipment-co-ltd/875aed37-2ad1-4cb7-a326-b647e10a42c3/