# China NMPA Product Recall - Physiological seawater nasal spray

Source: https://www.globalkeysolutions.net/records/china_product_recall/shenyang-dade-medical-device-products-co-ltd/46205e3e-cc19-4506-93af-6931d8a9bcd3/
Source feed: China

> China NMPA product recall for Physiological seawater nasal spray by Shenyang Dade Medical Device Products Co., Ltd. published October 29, 2019. Recall level: Level 3 Recall. Shenyang Dade Medical Device Products Co., Ltd. initiated a voluntary Class III recall of its physio

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shenyang Dade Medical Device Products Co., Ltd. is voluntarily recalling its physiological saline nasal spray.
- Company Name: Shenyang Dade Medical Device Products Co., Ltd.
- Publication Date: 2019-10-29
- Product Name: Physiological seawater nasal spray
- Recall Level: Level 3 Recall
- Recall Reason: The pH value of physiological saline nasal sprays is not within the range of 5.5-7.0 specified in the technical requirements for physiological saline nasal sprays.
- Discovering Company: Shenyang Dade Medical Device Products Co., Ltd.
- Manufacturing Company: Shenyang Dade Medical Device Products Co., Ltd.
- Summary: Shenyang Dade Medical Device Products Co., Ltd. initiated a voluntary Class III recall of its physiological saline nasal sprays, publicly reported on October 29, 2019, by the National Medical Products Administration (NMPA) and the Liaoning Provincial Drug Administration. The core issue driving this action was a quality deviation where the product's pH value did not conform to the specified technical requirement, which mandates a pH range of 5.5 to 7.0. The company identified this non-compliance internally, leading to its proactive decision to recall the affected medical devices, registered under Liaoning Medical Device Registration 20162660169. A Class III recall signifies that exposure to the product is not likely to cause serious adverse health consequences. While specific inspection dates are not detailed, the company's self-identification of the pH discrepancy prompted this regulatory action under the NMPA's oversight. This event highlights the critical importance of rigorous quality control and adherence to product specifications within China's medical device sector, with further product-specific details available in an accompanying recall report.

Company: https://www.globalkeysolutions.net/companies/shenyang-dade-medical-device-products-co-ltd/7c1ebb54-8613-4fd0-8ca8-53622ba5e463/