# China NMPA Product Recall - Expanded polytetrafluoroethylene artificial blood vessels

Source: https://www.keypedia.com/records/china_product_recall/bard-medical-technology-shanghai-co-ltd/20cac459-9443-45ad-9cb9-40d4fc06a4fa
Source feed: China

> China NMPA product recall for Expanded polytetrafluoroethylene artificial blood vessels by Bard Medical Technology (Shanghai) Co., Ltd. published September 24, 2021. Recall level: Level 3 Recall. Lemai Medical Technology (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Expanded

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Lema Medical Technology (Shanghai) Co., Ltd. has initiated a voluntary recall of expanded polytetrafluoroethylene (ePTFE) artificial blood vessels.
- Company Name: Bard Medical Technology (Shanghai) Co., Ltd.
- Publication Date: 2021-09-24
- Product Name: Expanded polytetrafluoroethylene artificial blood vessels
- Recall Level: Level 3 Recall
- Recall Reason: Issues such as incorrect printing of icons on inner packaging labels
- Discovering Company: LeMed Medical Technology (Shanghai) Co., Ltd.
- Manufacturing Company: Bard Medical Technology (Shanghai) Co., Ltd.
- Summary: Lemai Medical Technology (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Expanded Polytetrafluoroethylene (ePTFE) Artificial Blood Vessels. This action, reported on September 24, 2021, stems from a critical issue identified with the product's inner packaging. Specifically, the recall addresses incorrect printing of icons on the label, which could potentially lead to misinterpretation or misuse by healthcare professionals or patients. The affected products are registered under certificate number 20203130044. This recall is being managed under the regulatory oversight of the National Medical Products Administration (NMPA) and was initially reported via the Shanghai Municipal Drug Administration Website. While specific inspection dates are not provided, the recall date signifies the company's proactive response to identified quality control discrepancies. Lemai Medical Technology is taking the required action of removing the affected batches from distribution. Further details regarding the specific models, specifications, and batch numbers involved in this recall are available in the accompanying "Medical Device Recall Event Report Form," which stakeholders are encouraged to consult for comprehensive information. The company's voluntary action underscores its commitment to product safety and regulatory compliance.

Company: https://www.keypedia.com/companies/bard-medical-technology-shanghai-co-ltd/4bdd60c0-a2ea-4471-a538-4d3b6da1fcac