# China NMPA Product Recall - septal puncture needle

Source: https://www.globalkeysolutions.net/records/china_product_recall/merryton-medical-equipment-co-ltd-usa/c9f3d8ec-b30e-4d82-94e8-0b00c9bb7ac1/
Source feed: China

> China NMPA product recall for septal puncture needle by Merryton Medical Equipment Co., Ltd. (USA) published February 07, 2021. Recall level: Level 2 Recall. Meriton Medical Devices, Inc. (USA), in conjunction with its Beijing subsidiary, Meriton Medical Dev

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Meriton Medical Devices, Inc. of the United States is voluntarily recalling its transseptal puncture needles.
- Company Name: Merryton Medical Equipment Co., Ltd. (USA)
- Publication Date: 2021-02-07
- Product Name: septal puncture needle
- Recall Level: Level 2 Recall
- Recall Reason: The marked needle tip curvature may not match the actual needle tip curvature.
- Discovering Company: Mairuitong Medical Devices (Beijing) Co., Ltd.
- Manufacturing Company: Merryton Medical Equipment Co., Ltd. (USA)
- Summary: Meriton Medical Devices, Inc. (USA), in conjunction with its Beijing subsidiary, Meriton Medical Devices (Beijing) Co., Ltd., announced a voluntary Class II recall of certain models and batches of its atrial septal puncture needles on February 7, 2021. This action was initiated due to a critical discrepancy found between the marked needle tip curvature and the actual curvature of the devices. The National Medical Products Administration (NMPA) of China is overseeing this recall, classifying it as a Class II event, which indicates that the product defect could lead to temporary or medically reversible adverse health consequences, with a low probability of serious harm. As a required action, Meriton Medical Devices, Inc. is actively removing the affected products from circulation. Detailed information concerning the specific models, specifications, and batch numbers of the recalled needles is provided in the accompanying "Medical Device Recall Event Report Form" attachment, guiding stakeholders through the recall process to ensure patient safety and compliance with regulatory standards.

Company: https://www.globalkeysolutions.net/companies/merryton-medical-equipment-co-ltd-usa/86707790-eeb5-44b5-9827-31949bb3b597/