# China NMPA Product Recall - Self-adhesive soft silicone silver ion foam dressing

Source: https://www.globalkeysolutions.net/records/china_product_recall/mornik-medical-supplies-shanghai-co-ltd/b7d7605e-e452-4638-bc4c-a52372d83893/
Source feed: China

> China NMPA product recall for Self-adhesive soft silicone silver ion foam dressing by Mörnik Medical Supplies (Shanghai) Co., Ltd. published January 10, 2019. Recall level: Level 3 Recall. Mönch Medical Supplies (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its self-adhes

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Mönch Medical Supplies (Shanghai) Co., Ltd. is voluntarily recalling its self-adhesive soft silicone silver ion foam dressing.
- Company Name: Mörnik Medical Supplies (Shanghai) Co., Ltd.
- Publication Date: 2019-01-10
- Product Name: Self-adhesive soft silicone silver ion foam dressing
- Recall Level: Level 3 Recall
- Recall Reason: The issues involved were that the shelf life of the two batches of products mentioned above was inconsistent with the shelf life stated in the product instructions filed with the drug regulatory authority.
- Discovering Company: Mörnik Medical Supplies (Shanghai) Co., Ltd.
- Manufacturing Company: Mörnik Medical Supplies (Shanghai) Co., Ltd.
- Summary: Mönch Medical Supplies (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its self-adhesive soft polysilicone silver ion foam dressing (Registration Certificate No.: 20173641838), as announced on January 10, 2019. This action was taken due to significant discrepancies identified in the shelf life information for two specific product batches. The stated shelf life on the product did not align with the shelf life documented in the instructions submitted to the regulatory authorities. The recall, overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration (SFDA), underscores the importance of accurate product information. Companies are required to ensure all product specifications, including shelf life, precisely match the details registered with the relevant drug regulatory bodies. Mönch Medical Supplies (Shanghai) Co., Ltd. proactively addressed this issue by recalling the affected medical devices to maintain compliance and ensure product integrity. Further details regarding the specific models, specifications, and batch numbers of the recalled products are available in the "Medical Device Recall Report Form." This incident highlights the rigorous oversight by Chinese regulatory bodies in upholding medical device safety standards.

Company: https://www.globalkeysolutions.net/companies/mornik-medical-supplies-shanghai-co-ltd/1b7dd84f-cf59-4d12-85d4-840d3e7845b4/