# China NMPA Product Recall - Stoma base plate Estee Skin Barrier

Source: https://www.globalkeysolutions.net/records/china_product_recall/convatec-inc/a5c6b028-3859-4bae-99d7-c7f95950a84e/
Source feed: China

> China NMPA product recall for Stoma base plate Estee Skin Barrier by ConvaTec Inc. published December 06, 2024. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) has released details on a voluntary Class II rec

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: ConvaTec Inc. is voluntarily recalling ostomy chassis.
- Company Name: ConvaTec Inc.
- Publication Date: 2024-12-06
- Product Name: Stoma base plate Estee Skin Barrier
- Recall Level: Level 2 Recall
- Recall Reason: The label size does not match the actual product size.
- Discovering Company: Convide (China) Medical Supplies Co., Ltd.
- Manufacturing Company: ConvaTec Inc.
- Summary: The National Medical Products Administration (NMPA) has released details on a voluntary Class II recall initiated by ConvaTec Inc., reported by ConvaTec (China) Medical Supplies Co., Ltd. This recall, published on December 6, 2024, pertains to the Estee Skin Barrier ostomy baseplate (National Medical Device Registration No. 20181394). The core issue prompting this action is a manufacturing discrepancy where the labeled dimensions of the product do not match its actual dimensions. Although ConvaTec Inc. is the product's manufacturer, the recall was reported by its Chinese subsidiary under NMPA regulations. It is important to note that the specific batches of products subject to this recall were not imported into the Chinese market, thereby minimizing any direct impact on local consumers. This regulatory action underscores the NMPA's commitment to ensuring the quality and safety of medical devices. Further comprehensive details, including specific models, specifications, and batch numbers, are provided in the accompanying "Medical Device Recall Table" and the "Medical Device Recall Event Report Form" submitted by ConvaTec (China) Medical Supplies Co., Ltd. This voluntary recall demonstrates the company's proactive approach to addressing product inconsistencies.

Company: https://www.globalkeysolutions.net/companies/convatec-inc/8059b175-8606-43d1-9058-ff38e7324229/