# China NMPA Product Recall - Natural latex rubber condoms

Source: https://www.globalkeysolutions.net/records/china_product_recall/suretex-prophylactics-india-limited/27db1158-1938-4dd7-9f38-2e9ad0d4c1f2/
Source feed: China

> China NMPA product recall for Natural latex rubber condoms by Suretex Prophylactics (India) Limited published December 17, 2018. Recall level: Level 3. The National Medical Products Administration (NMPA) of China issued a Level 3 medical device recall,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medical Device Recall Event Report Form
- Company Name: Suretex Prophylactics (India) Limited
- Publication Date: 2018-12-17
- Product Name: Natural latex rubber condoms
- Recall Level: Level 3
- Recall Reason: Samples failed the random inspection of medical devices.
- Discovering Company: Anhui Provincial Drug Administration
- Manufacturing Company: Suretex Prophylactics (India) Limited
- Summary: The National Medical Products Administration (NMPA) of China issued a Level 3 medical device recall, detailed in a report published on December 17, 2018. This recall involved Natural Latex Rubber Condoms manufactured by Suretex Prophylactics (India) Limited and distributed in China by Wuhan Jissbon Hygiene Products Co., Ltd. The primary issue stemmed from product samples, specifically batch number LF170605, failing a routine medical device sampling inspection. This failure indicated a quality or safety non-conformity, prompting the regulatory action. Approximately 19,156 boxes of the affected "Non-gloss type" condoms were sold in China. A Level 3 recall, under the NMPA framework, signifies that while the product is violative, its use or exposure is not likely to cause adverse health consequences. In response, the company implemented several corrective actions: distributors were immediately instructed to halt sales of the affected batch, and all remaining products in warehouses and retail outlets were mandated for return. The recall process has been successfully completed, with all retrieved products securely sealed in the company's designated warehouse, demonstrating adherence to NMPA's safety standards.

Company: https://www.globalkeysolutions.net/companies/suretex-prophylactics-india-limited/525d148e-9ea0-42fa-919d-ff145a6271f6/