# China NMPA Product Recall - Partially sterilized products

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-shangyi-kangge-medical-equipment-co-ltd/ac17b337-51ae-4da8-951c-91b6a331e3d3/
Source feed: China

> China NMPA product recall for Partially sterilized products by Shanghai Shangyi Kangge Medical Equipment Co., Ltd. published December 07, 2016. Recall level: Level II. Shanghai Shangyi Kangge Medical Equipment Co., Ltd. initiated a Level II voluntary recall of several

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Shangyi Kangge Medical Equipment Co., Ltd. has voluntarily recalled some of its sterilized products.
- Company Name: Shanghai Shangyi Kangge Medical Equipment Co., Ltd.
- Publication Date: 2016-12-07
- Product Name: Partially sterilized products
- Recall Level: Level II
- Recall Reason: Since July 25, 2016, the Putuo sterilizer control software has been updated and upgraded, and the sterilizer manufacturer has adjusted the sterilization parameters. However, the company has not re-verified the sterilization process of the Putuo sterilizer. Although these batches of chemical indicators and bacterial tablets have passed inspection, there may still be a risk of infection or adverse reactions. As a precaution, these batches of products are being recalled.
- Discovering Company: Shanghai Shangyi Kangge Medical Equipment Co., Ltd.
- Manufacturing Company: Shanghai Shangyi Kangge Medical Equipment Co., Ltd.
- Summary: Shanghai Shangyi Kangge Medical Equipment Co., Ltd. initiated a Level II voluntary recall of several sterilized medical devices, as reported to the National Medical Products Administration (NMPA) on September 26, 2016, and publicly announced on December 7, 2016. The recall stems from a critical lapse in quality control. Following a control software update and sterilization parameter adjustments to their Putuo Sterilization Cabinet starting July 25, 2016, the company failed to reconfirm the revised sterilization process. This oversight means the sterility of affected products, despite initial chemical indicator and bacterial tablet inspections, could not be guaranteed, raising potential infection risks for patients. In response, Shanghai Shangyi Kangge Medical Equipment Co., Ltd. has taken several corrective actions. They proactively recalled all impacted product batches and immediately suspended the use of the Putuo sterilizer to undertake a comprehensive parameter reconfirmation. Furthermore, customers were promptly notified to cease using and isolate any affected unused products. The company also ensured all unsold affected inventory was isolated and sealed, confirming no related adverse events or customer complaints had been received at the time of the report. This action aligns with NMPA's regulatory expectations for medical device safety.

Company: https://www.globalkeysolutions.net/companies/shanghai-shangyi-kangge-medical-equipment-co-ltd/b663f56c-6d76-4e03-b34b-ae4c72de03f1/