# China NMPA Product Recall - Non-absorbent polyester sutures

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-medical-devices-international-trading-shanghai-co-ltd/dd3d0ecf-21f3-4d7b-8213-e60331fa381f/
Source feed: China

> China NMPA product recall for Non-absorbent polyester sutures by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. published January 13, 2020. Recall level: Level 3 Recall. Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien Medical Devices International Trading (Shanghai) Co., Ltd. is voluntarily recalling non-absorbable polyester sutures.
- Company Name: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-01-13
- Product Name: Non-absorbent polyester sutures
- Recall Level: Level 3 Recall
- Recall Reason: The product was found to be non-compliant in the national random inspection for the requirement that "the surface of multi-strand sutures (non-absorbent) should have a coating".
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Summary: Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its non-absorbable polyester sutures, as announced by the National Medical Products Administration (NMPA) on January 13, 2020. The recall was prompted after the product failed to meet national sampling standards for suture appearance, specifically concerning the required coating for multi-strand, non-absorbable sutures. This deficiency indicates a potential quality control issue where the product did not conform to established specifications, impacting its intended physical characteristics. The regulatory framework overseeing this action includes the NMPA and the Shanghai Municipal Drug Administration. Covidien's proactive measure in conducting a voluntary recall underscores its responsibility in addressing product non-conformance. Details regarding specific product models, specifications, and batch numbers are available in an attached Medical Device Recall Event Report Form, providing comprehensive information for affected parties. This recall ensures compliance with product quality standards and safeguards public health.

Company: https://www.globalkeysolutions.net/companies/covidien-medical-devices-international-trading-shanghai-co-ltd/4fdf08b9-af8e-4aed-8993-3e905e973d3b/