# China NMPA Product Recall - Calcium alginate dressing

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-medical-ltd/49932732-a24d-4ea4-b90b-1938ad6d09dd/
Source feed: China

> China NMPA product recall for Calcium alginate dressing by Smith & Nephew Medical Ltd published April 22, 2019. Recall level: Level 3. Smith & Nephew Medical Ltd, a UK-based manufacturer, initiated a voluntary Class III recall of its c

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Medical Ltd. voluntarily recalls calcium alginate dressings.
- Company Name: Smith & Nephew Medical Ltd
- Publication Date: 2019-04-22
- Product Name: Calcium alginate dressing
- Recall Level: Level 3
- Recall Reason: The affected products have discrepancies between the information regarding the shelf life, sterilization method, and instruction manual registered with the Russian Federal Service for Supervision of Public Health and Social Development and the actual product information.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Medical Ltd
- Summary: Smith & Nephew Medical Ltd, a UK-based manufacturer, initiated a voluntary Class III recall of its calcium alginate dressings (Registration Certificate No.: 20173646753) due to identified discrepancies. Reported by its agent, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., on April 9, 2019, and published by the National Medical Products Administration (NMPA) on April 22, 2019, the recall addresses critical inconsistencies. The primary issue involves a mismatch between the registered shelf life, sterilization method, and instructions for use information submitted to the Russian Federal Service for Supervision of Consumer Health and Social Development, and the actual product details. Affected product models include 66000519, 66000520, 66000521, and 66000522, impacting various batch numbers. While the recall specifically targets products sold in regions such as the Russian Federation, the document explicitly states that this recall does not affect the Chinese market, with zero reported product sales in China for the affected batches. The required action is a voluntary Class III recall to rectify these informational discrepancies.

Company: https://www.globalkeysolutions.net/companies/smith-nephew-medical-ltd/4492c705-9e7a-46fe-9ec4-5beea5d37a9e/