# China NMPA Product Recall - Epidural Catheters Sets and Kits

Source: https://www.globalkeysolutions.net/records/china_product_recall/arrow-international-inc/f226cf28-bac8-4ef0-93d6-372aae43cfe8/
Source feed: China

> China NMPA product recall for Epidural Catheters Sets and Kits by Arrow International Inc. published February 07, 2020. Recall level: Level 2 Recall. On February 7, 2020, the National Medical Products Administration (NMPA) announced a voluntary Class

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Arrow International Inc. is voluntarily recalling its Epidural Catheters Sets and Kits.
- Company Name: Arrow International Inc.
- Publication Date: 2020-02-07
- Product Name: Epidural Catheters Sets and Kits
- Recall Level: Level 2 Recall
- Recall Reason: We received complaints about various malfunctions, including loss of syringe resistance.
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Arrow International Inc.
- Summary: On February 7, 2020, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Arrow International Inc., concerning specific models and batches of its Epidural Catheters Sets and Kits (Registration Certificate No.: 20163660685). The recall was reported to the NMPA by Telefel Medical Devices Trading (Shanghai) Co., Ltd. This action was prompted by customer complaints detailing various malfunctions associated with the medical devices. A primary concern highlighted in these reports was the "loss of syringe resistance," which could potentially compromise the safe and effective use of the epidural catheter sets. The NMPA oversees medical device safety and ensures compliance with regulatory standards within China, making such recalls a critical measure to protect public health. Arrow International Inc. is undertaking this voluntary recall to address these significant product performance issues. While the document specifies a Class II recall, indicating a situation where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote, it underscores the manufacturer's responsibility to manage product defects. Affected product models, specifications, and batch details are comprehensively listed in the accompanying "Medical Device Recall Event Report Form," enabling healthcare providers and consumers to identify the impacted products and take necessary actions. The recall emphasizes adherence to stringent quality controls and prompt resolution of device performance concerns under the NMPA's regulatory framework.

Company: https://www.globalkeysolutions.net/companies/arrow-international-inc/8820e141-5ce7-4e2d-844a-672ff4232c9c/