# China NMPA Product Recall - Disposable infusion set with needle

Source: https://www.globalkeysolutions.net/records/china_product_recall/yunnan-haodi-medical-equipment-co-ltd/3f40d1b5-9900-46a6-9805-625666e473ee/
Source feed: China

> China NMPA product recall for Disposable infusion set with needle by Yunnan Haodi Medical Equipment Co., Ltd. published October 19, 2021. Recall level: Level 3 Recall. Yunnan Haodi Medical Device Co., Ltd. has initiated a voluntary Class III recall of its disposable i

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Yunnan Haodi Medical Devices Co., Ltd. has initiated a voluntary recall of disposable infusion sets containing needles.
- Company Name: Yunnan Haodi Medical Equipment Co., Ltd.
- Publication Date: 2021-10-19
- Product Name: Disposable infusion set with needle
- Recall Level: Level 3 Recall
- Recall Reason: Product labels and markings are untrue and inaccurate.
- Discovering Company: Yunnan Haodi Medical Equipment Co., Ltd.
- Manufacturing Company: Yunnan Haodi Medical Equipment Co., Ltd.
- Summary: Yunnan Haodi Medical Device Co., Ltd. has initiated a voluntary Class III recall of its disposable infusion sets with needles. This action, reported on October 19, 2021, stems from the discovery of inaccurate and untrue product labels and markings associated with these medical devices (Registration No.: 20163660604). The National Medical Products Administration (NMPA) oversees this regulatory action, as detailed on the Yunnan Provincial Drug Administration Website. The core issue involves non-compliance with labeling standards, where the information presented on the product labels and markings was found to be misleading or incorrect. While the document does not specify inspection dates, the company's proactive voluntary recall indicates an internal identification of this critical issue impacting product integrity and user information. As a required action, Yunnan Haodi Medical Device Co., Ltd. is actively recalling the affected batches, models, and specifications of the disposable infusion sets with needles. The Class III classification suggests that the product defect is unlikely to cause adverse health consequences, but the mislabeling still represents a significant regulatory non-conformance. This recall underscores the importance of stringent quality control and adherence to precise labeling regulations within the medical device industry to ensure patient safety and product reliability. Further details regarding the specific affected products are available in the "Medical Device Report Form" attachment.

Company: https://www.globalkeysolutions.net/companies/yunnan-haodi-medical-equipment-co-ltd/276cb2bd-c6d8-4484-a3c3-21db967081ed/