# China NMPA Product Recall - Two-piece ostomy pouch

Source: https://www.globalkeysolutions.net/records/china_product_recall/convatec-limited/c9cb8e0e-4474-44d0-a742-86878121f8f6
Source feed: China

> China NMPA product recall for Two-piece ostomy pouch by ConvaTec Limited published February 28, 2022. Recall level: Level 3 Recall. ConvaTec Limited has initiated a Class III voluntary recall of specific two-piece ostomy pouches due

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: ConvaTec Limited is voluntarily recalling its two-piece ostomy pouch.
- Company Name: ConvaTec Limited
- Publication Date: 2022-02-28
- Product Name: Two-piece ostomy pouch
- Recall Level: Level 3 Recall
- Recall Reason: The problem of leakage at the connection between the cap and the bag itself of the ostomy bags produced on the FUT production line (CvT, MCH)
- Discovering Company: Convide (China) Medical Supplies Co., Ltd.
- Manufacturing Company: ConvaTec Limited
- Summary: ConvaTec Limited has initiated a Class III voluntary recall of specific two-piece ostomy pouches due to a critical manufacturing defect. The primary issue identified is a leakage occurring at the connection point between the cap and the pouch itself. This defect affects particular models and batches of products that were manufactured on the FUT (CvT, MCH) production line, identifiable by the registration certificate code 国械备20140099. Such a defect poses a direct risk to patient well-being, potentially leading to discomfort, infection, or compromised medical care. This significant recall is being executed under the regulatory oversight of the National Medical Products Administration (NMPA) of China. ConvaTec (China) Medical Supplies Co., Ltd. was responsible for reporting the issue to the NMPA, leading to the manufacturer's prompt recall action. The official notification and comprehensive documentation, including a detailed Medical Device Recall Event Report Form, were publicly released on February 28, 2022, marking the commencement of the recall process. The required action mandates the manufacturer to retrieve all identified defective products from the market. Comprehensive details regarding the specific affected product models, specifications, and batch numbers are available in the attached recall event report. This decisive, voluntary action by ConvaTec underscores their commitment to product quality and patient safety, aiming to prevent any further adverse events associated with the faulty devices.

Company: https://www.globalkeysolutions.net/companies/convatec-limited/e7b1f4b8-dd45-4eac-b884-243d6922514f