# China NMPA Product Recall - Infusion pump (product name: Zhenxing)

Source: https://www.globalkeysolutions.net/records/china_product_recall/hospira-inc/81fb74df-0584-4d90-ab69-1441c0a94040/
Source feed: China

> China NMPA product recall for Infusion pump (product name: Zhenxing) by Hospira, Inc. published January 28, 2014. Recall level: Level 1 Recall. Hospira, Inc. initiated a global, Level 1 voluntary recall of its infusion pumps (Trade Name: Zhenxi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Hospira, Inc. of the United States is recalling its infusion pumps.
- Company Name: Hospira, Inc.
- Publication Date: 2014-01-28
- Product Name: Infusion pump (product name: Zhenxing)
- Recall Level: Level 1 Recall
- Recall Reason: Calibration misalignment of the upper and lower pressure sensors can cause the pump to fail to detect blockages and thus fail to issue corresponding alarms, or to generate false alarms (Card Check - D, Card Check - P, Upper Blockage, Lower Blockage, Pressure Calibration Error, Pressure Sensor Event Failure, Pressure Sensor Status Failure, Lower Pressure Out of Range, Upper Sensor Out of Range). This problem may cause treatment delays or interruptions, or an overdose of up to 1 mL. The severity of treatment delays or interruptions and overdose depends on the patient's condition and the treatment used; in the worst case, it may cause serious injury or death.
- Discovering Company: Shanghai Municipal Food and Drug Administration
- Manufacturing Company: Hospira, Inc.
- Summary: Hospira, Inc. initiated a global, Level 1 voluntary recall of its infusion pumps (Trade Name: Zhenxing) due to critical calibration issues. The recall, reported by the Shanghai Municipal Food and Drug Administration on January 28, 2014, affects pumps manufactured after January 1, 2009, or those with replaced pressure sensors. The primary concern is the misalignment of upper and lower pressure sensors, which can lead to the device failing to detect blockages and thus not issuing crucial alarms, or conversely, generating false alarms. This malfunction poses significant patient safety risks, potentially causing treatment delays, interruptions, or even over-infusion of up to 1 mL. In severe cases, these issues could result in serious injury or death, depending on the patient's condition and treatment. The recall adheres to the regulatory framework outlined in the Ministry of Health of the People's Republic of China Order No. 82, "Administrative Measures for the Recall of Medical Devices (Trial Implementation)." Hospira's required corrective actions include deploying engineers to perform immediate occlusion tests, withdrawing failing pumps for recalibration, incorporating annual occlusion testing into maintenance plans, and revising technical service manuals. The company also committed to notifying all stakeholders via its website and direct communication.

Company: https://www.globalkeysolutions.net/companies/hospira-inc/a4171595-02e8-4c29-8a61-0dbcba50e4ac/