# China NMPA Product Recall - Disposable laparoscopic trocar

Source: https://www.globalkeysolutions.net/records/china_product_recall/changzhou-haiers-medical-device-technology-co-ltd/fe4e5513-391a-4580-85d4-822bef1ec3c0/
Source feed: China

> China NMPA product recall for Disposable laparoscopic trocar by Changzhou Haiers Medical Device Technology Co., Ltd. published January 11, 2019. Recall level: Level 3 Recall. Changzhou Haiers Medical Device Technology Co., Ltd. has initiated a voluntary Class III recall of i

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Changzhou Haiers Medical Devices Technology Co., Ltd. has initiated a voluntary recall of disposable laparoscopic trocars.
- Company Name: Changzhou Haiers Medical Device Technology Co., Ltd.
- Publication Date: 2019-01-11
- Product Name: Disposable laparoscopic trocar
- Recall Level: Level 3 Recall
- Recall Reason: In the 2018 national medical device spot check, it failed to meet the standards for the "fitting performance" item.
- Discovering Company: Changzhou Haiers Medical Device Technology Co., Ltd.
- Manufacturing Company: Changzhou Haiers Medical Device Technology Co., Ltd.
- Summary: Changzhou Haiers Medical Device Technology Co., Ltd. has initiated a voluntary Class III recall of its disposable laparoscopic puncture instruments. This action stems from findings during a 2018 national medical device spot check, which identified non-compliance with established standards regarding the product's "fitting performance." The National Medical Products Administration (NMPA) oversees this regulatory framework, ensuring medical device quality and safety. The specific violation indicates a potential issue with how components of the instruments fit together, which could impact their intended function or safety during use. As part of the required actions, Changzhou Haiers Medical Device Technology Co., Ltd. must provide detailed information on affected product models, specifications, and batches, documented in a "Medical Device Report Form." This information, along with the recall process, must be submitted to the Provincial Food Safety Authority to ensure proper oversight and resolution of the quality concern.

Company: https://www.globalkeysolutions.net/companies/changzhou-haiers-medical-device-technology-co-ltd/ea37d5df-b56f-4c05-8c33-09f123422b26/