# China NMPA Product Recall - Laparoscopic surgical instruments

Source: https://www.globalkeysolutions.net/records/china_product_recall/microline-surgical-inc/6ba95a77-abf5-491e-9498-f03bd8e5fa1d/
Source feed: China

> China NMPA product recall for Laparoscopic surgical instruments by Microline Surgical, Inc. published July 28, 2017. Recall level: Level 3 Recall. On July 28, 2017, the National Medical Products Administration (NMPA) issued a Medical Device Recall

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medical Device Recall Event Report Form
- Company Name: Microline Surgical, Inc.
- Publication Date: 2017-07-28
- Product Name: Laparoscopic surgical instruments
- Recall Level: Level 3 Recall
- Recall Reason: The insulating layer made of black heat-shrink material on the ReNew repetitive manipulation heads (grasping forceps and dissecting forceps) has a potential risk of cracking after high-temperature and high-pressure sterilization/re-sterilization. As of now, Microline has not received any feedback from patients who have been harmed, but in order to avoid potential risks, the manufacturer has taken the initiative to recall the product.
- Discovering Company: Tianjin Qingsong Huayao Pharmaceutical Co., Ltd.
- Manufacturing Company: Microline Surgical, Inc.
- Summary: On July 28, 2017, the National Medical Products Administration (NMPA) issued a Medical Device Recall Event Report concerning Laparoscopic Surgical Instruments manufactured by MICROLINE SURGICAL INC. The recall was initiated by the recalling unit, Tianjin Qingsong Huayao Pharmaceutical Co., Ltd. The primary issue identified was a potential risk where the insulating layer on the repetitive manipulation heads (grasping and dissecting forceps), made of black heat-shrink material, could crack after high-temperature, high-pressure sterilization or re-sterilization. Although no patient harm reports had been received, the manufacturer proactively initiated a global Level 3 recall to mitigate potential risks. This recall affects 70 imported batches, totaling 2245 units, with 849 units sold in China.

Operating under the NMPA's regulatory framework for medical device recalls, specific actions are required. The recalling unit is mandated to issue recall notices to all domestic customers and secure confirmation receipts for these communications. Additionally, all recalled products must be returned to MICROLINE SURGICAL INC for appropriate processing. This proactive measure underscores a commitment to patient safety by addressing potential device degradation risks post-sterilization.

Company: https://www.globalkeysolutions.net/companies/microline-surgical-inc/cd08eb9f-d203-4b38-b5b4-4f5344957a6e/