# China NMPA Product Recall - Non-absorbable surgical silk sutures

Source: https://www.globalkeysolutions.net/records/china_product_recall/jiahe-medical-materials-suzhou-co-ltd/950d6e11-afa9-4510-b642-0e2e94d38666/
Source feed: China

> China NMPA product recall for Non-absorbable surgical silk sutures by Jiahe Medical Materials (Suzhou) Co., Ltd. published March 11, 2021. Recall level: Level 3 Recall. Jiahe Medical Materials (Suzhou) Co., Ltd. voluntarily initiated a Level III recall for its non-abso

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Jiahe Medical Materials (Suzhou) Co., Ltd. voluntarily recalls non-absorbable surgical silk sutures.
- Company Name: Jiahe Medical Materials (Suzhou) Co., Ltd.
- Publication Date: 2021-03-11
- Product Name: Non-absorbable surgical silk sutures
- Recall Level: Level 3 Recall
- Recall Reason: Product label printing error
- Discovering Company: Jiahe Medical Materials (Suzhou) Co., Ltd.
- Manufacturing Company: Jiahe Medical Materials (Suzhou) Co., Ltd.
- Summary: Jiahe Medical Materials (Suzhou) Co., Ltd. voluntarily initiated a Level III recall for its non-absorbable surgical silk sutures, as reported on March 11, 2021, to the National Medical Products Administration (NMPA) and the Jiangsu Provincial Drug Administration. The main issue identified was incorrect labeling on the product's outer packaging, where "Batch Code" and "Production Date" were printed instead of "Manufacturing Date." While the company initially stated this labeling error did not impact product performance, the recall report form also contained a contradictory statement implying that performance was affected. This recall, affecting 63,400 packages distributed across China, falls under the NMPA's regulatory framework for medical devices. As a Level III recall, it generally signifies a low probability of adverse health consequences. Required actions include the return of all affected products to Jiahe Medical Materials (Suzhou) Co., Ltd., along with the company's responsibility to notify distributors and hospitals about the recall and manage the return process according to established medical device recall procedures.

Company: https://www.globalkeysolutions.net/companies/jiahe-medical-materials-suzhou-co-ltd/13480493-0e76-43df-9597-3e34248d6437/