# China NMPA Product Recall - Medical bed-type air mattress products

Source: https://www.globalkeysolutions.net/records/china_product_recall/longkou-kanghua-medical-equipment-co-ltd/9a5eae2d-1519-4292-87c0-51bcc8b0cf30/
Source feed: China

> China NMPA product recall for Medical bed-type air mattress products by Longkou Kanghua Medical Equipment Co., Ltd. published December 14, 2018. Recall level: Level 3 Recall. Longkou Kanghua Medical Device Co., Ltd. enacted a voluntary Level III recall on December 14, 2018, 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Longkou Kanghua Medical Device Co., Ltd. has voluntarily recalled its medical bed-type air cushion product (batch number 20170601).
- Company Name: Longkou Kanghua Medical Equipment Co., Ltd.
- Publication Date: 2018-12-14
- Product Name: Medical bed-type air mattress products
- Recall Level: Level 3 Recall
- Recall Reason: The output air pressure exceeds the product registration standard pressure value, and the mark durability test is not passed.
- Discovering Company: Longkou Kanghua Medical Equipment Co., Ltd.
- Manufacturing Company: Longkou Kanghua Medical Equipment Co., Ltd.
- Summary: Longkou Kanghua Medical Device Co., Ltd. enacted a voluntary Level III recall on December 14, 2018, for its medical bed-type air cushion product, specifically Batch No. 20170601. This significant action was prompted by the identification of two critical product non-conformities. Firstly, the output air pressure of the affected medical bed-type air cushions was found to exceed the product’s registered standard pressure value, which could impact patient safety or product efficacy. Secondly, the product failed the mark durability test, indicating that essential product information or warnings might not remain legible throughout the product's intended lifespan. Operating under the oversight of the National Medical Products Administration (NMPA), the company initiated this recall to ensure compliance with medical device regulations. The decision reflects Longkou Kanghua Medical Device Co., Ltd.'s commitment to addressing product quality concerns proactively. The regulatory framework necessitates such actions to protect public health. Affected entities or individuals were instructed to consult the "Medical Device Recall Event Report Form" for comprehensive details on specific models, specifications, and batch numbers involved in the recall, facilitating the efficient removal of non-compliant products from circulation.

Company: https://www.globalkeysolutions.net/companies/longkou-kanghua-medical-equipment-co-ltd/c2222b3e-3bfd-4e1a-a38d-94d686b30c6f/