# 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/87a0366b-7382-455d-a703-303fc82afd54/
Source feed: China

> China NMPA product recall for Medical bed-type air mattress products by Longkou Kanghua Medical Equipment Co., Ltd. published December 17, 2018. Recall level: Level 3 Recall. Longkou Kanghua Medical Device Co., Ltd., operating under the regulatory framework of the National M

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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: 2018-12-17
- Product Name: Medical bed-type air mattress products
- Recall Level: Level 3 Recall
- Recall Reason: Output air pressure exceeds product registration standard pressure value, marking durability test
- Discovering Company: Longkou Kanghua Medical Equipment Co., Ltd.
- Manufacturing Company: Longkou Kanghua Medical Equipment Co., Ltd.
- Summary: Longkou Kanghua Medical Device Co., Ltd., operating under the regulatory framework of the National Medical Products Administration (NMPA), initiated a voluntary Level III recall of its medical bed-type air cushion product. This recall, publicly announced on December 17, 2018, specifically affects products from Batch No. 20170601. The main issues identified were that the output air pressure of the medical bed-type air cushions exceeded the established product registration standard pressure value. Furthermore, the marking durability test results were unsatisfactory, indicating a deviation from required quality specifications. The company proactively reported these findings and implemented the recall for products registered under No. Lu Shi Yao Jian Xie [Zhun] Zi 2014 No. 2540639. A Level III recall typically indicates that the product is unlikely to cause adverse health consequences. This measure reflects the company's commitment to ensuring product safety and compliance with NMPA regulations, safeguarding patient well-being by addressing performance and quality control deficiencies.

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