# China NMPA Product Recall - Disposable maternity pack

Source: https://www.globalkeysolutions.net/records/china_product_recall/nanchang-medical-equipment-co-ltd/5a74482b-1923-4900-b6a9-17a9a49bbfe5
Source feed: China

> China NMPA product recall for Disposable maternity pack by Nanchang Medical Equipment Co., Ltd. published January 10, 2020. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nanchang Kang Sheng Medical Device Co., Ltd. reported a voluntary recall of its disposable medical device packaging (Registration Certificate No.: Ganxiezhuzhun 20162640177) due to non-compliance with standards regarding residual ethylene oxide content. The recall is classified as Level III. Detailed information regarding the affected product models, specifications, and batches can be found in the "Medical Device Recall Event Report Form."
- Company Name: Nanchang Medical Equipment Co., Ltd.
- Publication Date: 2020-01-10
- Product Name: Disposable maternity pack
- Recall Level: Level 3 Recall
- Recall Reason: The residual ethylene oxide content in disposable packaging products failed to meet the standard requirements.
- Discovering Company: Nanchang Kang Sheng Medical Equipment Co., Ltd.
- Manufacturing Company: Nanchang Medical Equipment Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Nanchang Kang Sheng Medical Device Co., Ltd., publicized on January 10, 2020. The recall pertains to the company's disposable delivery kits, identified by Registration Certificate No. Ganxiezhuzhun 20162640177. The primary reason for this action is that the ethylene oxide residue levels in these kits failed to meet established standard requirements, indicating a critical non-conformance in their sterilization process. As part of its regulatory obligations and commitment to product safety, Nanchang Kang Sheng Medical Device Co., Ltd. is undertaking the necessary steps to remove the affected products from distribution. This recall highlights the stringent quality control necessary for medical devices, particularly regarding sterilization, to ensure patient safety under the regulatory framework overseen by the NMPA. Further specifics on the product specifications and involved batches are available in the official Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/nanchang-medical-equipment-co-ltd/7015714e-5b20-4940-b684-b1e40cb5f2ff