# China NMPA Product Recall - Soft Tissue Punch

Source: https://www.globalkeysolutions.net/records/china_product_recall/omnia-ag/43375b0a-8923-4093-898e-82df6b30499d/
Source feed: China

> China NMPA product recall for Soft Tissue Punch by Omnia AG published April 26, 2021. Recall level: Level 2 Recall. Novobio Trading (Shanghai) Co., Ltd., acting on behalf of manufacturer Omnia AG, has initiated a vol

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Noboco Trading (Shanghai) Co., Ltd. is voluntarily recalling its Soft Tissue Punch.
- Company Name: Omnia AG
- Publication Date: 2021-04-26
- Product Name: Soft Tissue Punch
- Recall Level: Level 2 Recall
- Recall Reason: The sterilization process of some batches of soft tissue circumcision scalpels had problems, which may have affected their aseptic performance.
- Discovering Company: Nobocom Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Omnia AG
- Summary: Novobio Trading (Shanghai) Co., Ltd., acting on behalf of manufacturer Omnia AG, has initiated a voluntary Class II recall for specific batches of soft tissue punches. This action, overseen by the National Medical Products Administration (NMPA), arises from identified deficiencies in the sterilization process for certain products. The primary concern is that these sterilization issues could compromise the aseptic performance of the devices, potentially impacting patient safety during surgical procedures. The document does not specify inspection dates. The recall specifically targets soft tissue punches, including those under registration certificate number 20152172936. Novobio Trading (Shanghai) Co., Ltd. is responsible for executing this recall within the market, and detailed information regarding affected models and batch numbers is available via a "Medical Device Recall Event Report Form." This proactive measure aligns with the NMPA's regulatory framework, demonstrating a commitment to product quality and patient safety by promptly addressing manufacturing issues and removing potentially compromised medical devices from circulation.

Company: https://www.globalkeysolutions.net/companies/omnia-ag/ae5ef8bb-2211-421b-9ed4-05cd7dbff1cf/