# China NMPA Product Recall - Laparoscopic surgical instruments

Source: https://www.globalkeysolutions.net/records/china_product_recall/microline-surgical-inc/913c037c-9927-4efc-bfb7-ddcca7f5bde8
Source feed: China

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

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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 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) processed a Medical Device Recall Event Report concerning laparoscopic surgical instruments manufactured by MICROLINE SURGICAL INC., with Tianjin Qingsong Huayao Pharmaceutical Co., Ltd. acting as the agent in China. This global Level 3 recall was initiated due to a potential safety issue with the insulating layer on the repetitive manipulation heads (grasping and dissecting forceps) of these instruments. The black heat-shrink material used for insulation presented a risk of cracking after high-temperature, high-pressure sterilization or re-sterilization. While the manufacturer, Microline, confirmed no patient harm reports had been received, the recall was proactively enacted to prevent potential risks during surgical procedures. The recall in China affects 70 imported batches, totaling 2245 units across various models and specifications, identified by specific product codes. Required actions include issuing recall notices to all domestic customers, obtaining confirmation receipts, and returning all affected products to the manufacturer for appropriate processing, ensuring adherence to regulatory standards and patient safety.

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