# China NMPA Product Recall - Multifunctional electrode (accessory for defibrillator monitor)

Source: https://www.globalkeysolutions.net/records/china_product_recall/shenzhen-mindray-bio-medical-electronics-co-ltd/3229929c-0a14-42ed-84bc-2f5e96cdc033/
Source feed: China

> China NMPA product recall for Multifunctional electrode (accessory for defibrillator monitor) by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. published August 21, 2017. Recall level: Level 3 Recall. Shenzhen Mindray Bio-Medical Electronics Co., Ltd. initiated a voluntary Level III recall of its Mul

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. is voluntarily recalling its multifunctional electrodes (accessories for defibrillators).
- Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Publication Date: 2017-08-21
- Product Name: Multifunctional electrode (accessory for defibrillator monitor)
- Recall Level: Level 3 Recall
- Recall Reason: The Chinese label on the outer packaging of the multifunctional electrode pads has a printing error for the "Product Name".
- Discovering Company: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Manufacturing Company: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Summary: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. initiated a voluntary Level III recall of its Multifunctional Electrode, a defibrillator accessory. This action, reported to the National Medical Products Administration (NMPA) on August 21, 2017, was prompted by a significant labeling error. The Chinese label on the outer packaging of the multifunctional electrode pad contained an incorrect "Product Name." The recall addresses products identified under NMPA Approval No. 20133211733. While specific inspection dates are not provided, the company is taking proactive steps to rectify this product identification and labeling inaccuracy, which is crucial for medical device regulatory compliance. Further details regarding affected product models, specifications, and batch numbers are available in the "Recall Event Report Form" provided by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. This voluntary recall emphasizes the critical importance of accurate labeling for medical devices to ensure proper product identification and user safety.

Company: https://www.globalkeysolutions.net/companies/shenzhen-mindray-bio-medical-electronics-co-ltd/f6d8536c-c1ec-4b07-a495-a1aa8ac9d9db/
