# China NMPA Product Recall - PTA balloon dilation catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/bard-peripheral-vascular-inc/00743760-c9c1-4689-ba30-2e3c11259746/
Source feed: China

> China NMPA product recall for PTA balloon dilation catheter by Bard Peripheral Vascular, Inc. published November 23, 2020. Recall level: Level 3 Recall. Bard Peripheral Vascular, Inc. has initiated a voluntary Class III recall of its PTA balloon dilatat

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bard Peripheral Vascular, Inc. is proactively recalling its PTA balloon dilation catheters.
- Company Name: Bard Peripheral Vascular, Inc.
- Publication Date: 2020-11-23
- Product Name: PTA balloon dilation catheter
- Recall Level: Level 3 Recall
- Recall Reason: Issue involving incorrect packaging of specific product models and batches
- Discovering Company: Bard Medical Technology (Shanghai) Co., Ltd.
- Manufacturing Company: Bard Peripheral Vascular, Inc.
- Summary: Bard Peripheral Vascular, Inc. has initiated a voluntary Class III recall of its PTA balloon dilatation catheters, a decision formally reported by Bard Medical Technology (Shanghai) Co., Ltd. and subsequently publicized by the National Medical Products Administration (NMPA) on November 23, 2020. The recall commenced on November 20, 2020, stemming from a critical packaging error identified across specific models and batches of the affected devices. This issue specifically targets the PTA balloon dilatation catheters, registered under Certificate No. 20183032612. While the document does not elaborate on the exact nature or potential impact of the packaging error, such discrepancies typically compromise product sterility, integrity, or proper identification, necessitating immediate corrective action to safeguard patient well-being. The NMPA, functioning as the authoritative regulatory body, mandates and oversees such recall procedures to ensure adherence to medical device standards and protect public health within its jurisdiction. This voluntary action by Bard Peripheral Vascular, Inc. underscores the company's responsibility in managing product quality and compliance. Detailed information concerning the precise models, specifications, and batch numbers impacted by this recall is provided in the "Medical Device Recall Event Report Form" attached to the official NMPA notice. This proactive measure by the company highlights the essential regulatory framework governing medical devices, ensuring that manufacturers address identified issues promptly and effectively.

Company: https://www.globalkeysolutions.net/companies/bard-peripheral-vascular-inc/12056f40-c9c7-45e9-b305-900ec162d183/