# China NMPA Product Recall - Disposable medical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/guangdong-baihe-medical-technology-co-ltd/d54d5798-fbdf-4a9e-82de-d10d8bb28dc8/
Source feed: China

> China NMPA product recall for Disposable medical masks by Guangdong Baihe Medical Technology Co., Ltd published August 26, 2022. Recall level: . Guangdong Bio-Con Medical Technology Co., Ltd., now operating as Guangdong Mingli Medical Technology

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Guangdong Bio-Health Medical Technology Co., Ltd. has voluntarily recalled disposable medical masks.
- Company Name: Guangdong Baihe Medical Technology Co., Ltd
- Publication Date: 2022-08-26
- Product Name: Disposable medical masks
- Recall Reason: The tensile strength at the connection point of the mask body is less than 10N, and the ventilation resistance of some masks is greater than 49Pa/cm², which does not meet the technical requirements of Guangdong Medical Device Registration Certificate 20202141141 "Disposable Medical Masks".
- Discovering Company: Guangdong Bio-Health Medical Technology Co., Ltd.
- Manufacturing Company: Guangdong Baihe Medical Technology Co., Ltd
- Summary: Guangdong Bio-Con Medical Technology Co., Ltd., now operating as Guangdong Mingli Medical Technology Co., Ltd., has initiated a voluntary recall of specific batches of its disposable medical masks. This action, announced by the National Medical Products Administration (NMPA) on August 26, 2022, addresses products from production batch numbers 20210104 and 20220104.

The recall stems from identified product deficiencies that pose potential concerns regarding mask efficacy and user safety. Specifically, the masks were found to have insufficient tensile strength, measuring below 10N at the connection points, which could compromise their integrity during use. Additionally, some masks exhibited ventilation resistance greater than 49Pa/cm

², which falls outside acceptable parameters and could affect breathability. These findings indicate a clear non-conformance with the stringent technical requirements stipulated in the Guangdong Medical Device Registration Standard 20202141141 for "Disposable Medical Masks." As a result, the company is undertaking a voluntary recall, a required action under the regulatory framework to ensure all medical devices meet established quality and safety benchmarks.

Company: https://www.globalkeysolutions.net/companies/guangdong-baihe-medical-technology-co-ltd/79d2e901-9843-48f0-8311-ef9f3c32b884/