# China NMPA Product Recall - Disposable medical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/zhumadian-taoerning-pharmaceutical-and-medical-equipment-co-ltd/49b5381e-dc25-4e18-bb3b-4de32e1e6e66/
Source feed: China

> China NMPA product recall for Disposable medical masks by Zhumadian Taoerning Pharmaceutical and Medical Equipment Co., Ltd. published October 22, 2020. Recall level: Level 3 Recall. Zhumadian Taoerning Pharmaceutical and Medical Device Co., Ltd. has initiated a voluntary Level III 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zhumadian Taoerning Pharmaceutical and Medical Equipment Co., Ltd. has voluntarily recalled disposable medical masks.
- Company Name: Zhumadian Taoerning Pharmaceutical and Medical Equipment Co., Ltd.
- Publication Date: 2020-10-22
- Product Name: Disposable medical masks
- Recall Level: Level 3 Recall
- Recall Reason: The breaking strength at the connection point between the mask strap and the mask kickstand is substandard.
- Discovering Company: Zhumadian Taoerning Pharmaceutical and Medical Equipment Co., Ltd.
- Manufacturing Company: Zhumadian Taoerning Pharmaceutical and Medical Equipment Co., Ltd.
- Summary: Zhumadian Taoerning Pharmaceutical and Medical Device Co., Ltd. has initiated a voluntary Level III recall for two batches of its disposable medical masks, as reported to the National Medical Products Administration (NMPA) on October 22, 2020. This action follows an assessment by the Henan Provincial Medical Device Inspection Institute, which identified a critical quality issue: the breaking strength at the connection point between the mask strap and the mask was substandard.

The affected products include masks with models 145
×95mm (small size, ear loop type) from batch number 20040601, and 175
×95mm (medium size, ear loop type) from batch number 20050601. Of the substantial quantities manufactured, 14,000 pieces from the first batch and 31,500 pieces from the second batch were distributed and sold within China. These masks are intended for clinical medical personnel during invasive procedures to protect both patients and healthcare providers from the spread of contaminants like blood and body fluids.

Under the guidance of the Henan Provincial Drug Administration, the company's required actions involve issuing a recall notice and actively contacting customers to retrieve the non-compliant masks. The recall process is currently underway to ensure the removal of these substandard products from circulation and uphold patient and user safety standards. The voluntary recall demonstrates the company's commitment to addressing quality deficiencies in compliance with medical device regulations.

Company: https://www.globalkeysolutions.net/companies/zhumadian-taoerning-pharmaceutical-and-medical-equipment-co-ltd/c2391659-00a0-4ced-a167-a87514ff3e1a/