# China NMPA Product Recall - Pressure pump unit

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/ae88c94b-2793-4a2e-ae8f-6dcf4093e571
Source feed: China

> China NMPA product recall for Pressure pump unit by Medtronic Inc. published February 25, 2014. Recall level: . Medtronic, Inc. initiated a voluntary recall on February 13, 2014, for a specific batch of its Press

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic, Inc. of the United States has recalled pressure pump units.
- Company Name: Medtronic Inc.
- Publication Date: 2014-02-25
- Product Name: Pressure pump unit
- Recall Reason: Medtronic has confirmed that the main label title for the Everest 20 Survival Kit (lot number 50755851, model AC2205P) is incorrect. The main label on the outside of the carton for this batch of products is incorrect; it identifies the product as Everest 30 Survival Kit, while the correct label should be Everest 20 Survival Kit. All other labels and packaging contents correctly identify the product as Everest 20 Survival Kits, and other batches have not been affected. This labeling error has not caused any adverse health consequences or harm to patients.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic, Inc. initiated a voluntary recall on February 13, 2014, for a specific batch of its Pressure Pump Devices (model AC2205P, batch number 50755851). This action was reported to China's National Medical Products Administration (NMPA) on February 14, 2014. The primary issue identified was an incorrect main label title on the outer carton; products were mistakenly identified as 'Everest 30 Survival Kit' when they should have been labeled 'Everest 20 Survival Kit.' All other product labels and contents were correct, and Medtronic confirmed that this labeling discrepancy had not resulted in any adverse health consequences or patient harm. Although the affected products were not distributed or sold in China, Medtronic (Shanghai) Management Co., Ltd. served as the local reporting unit. Under its regulatory framework, the NMPA responded by requesting provincial and regional Food and Drug Administrations to strengthen their oversight of similar medical devices, emphasizing the importance of accurate product identification for global market safety.

Company: https://www.globalkeysolutions.net/companies/medtronic-inc/398d5f72-c7d2-4c97-94fc-fbef4cf2336d