# China NMPA Product Recall - Tissue grasping forceps for endoscopic surgery

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-llc/367e7615-7cac-4eb3-9334-e013c4d022a0/
Source feed: China

> China NMPA product recall for Tissue grasping forceps for endoscopic surgery by Covidien llc published March 21, 2019. Recall level: Level 2 Recall. Covidien LLC initiated a voluntary Class II recall of its Tissue Grasping Forceps for Endoscopic Sur

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien LLC actively recalls tissue grasping forceps used in endoscopic surgery.
- Company Name: Covidien llc
- Publication Date: 2019-03-21
- Product Name: Tissue grasping forceps for endoscopic surgery
- Recall Level: Level 2 Recall
- Recall Reason: The reason for this voluntary recall is that during our review of product manufacturing records, we identified that the sterilization methods used in certain batches of endoscopic surgical tissue grasping forceps differed from the approved and labeled methods. These products are labeled as requiring V-ray sterilization, but in some cases, they were re-sterilized using ethylene oxide or repeated V-ray sterilization. While re-sterilization with ethylene oxide does not affect product performance, it is inconsistent with the labeled sterilization method. Furthermore, re-sterilization with V-rays increases the likelihood of product failure and component decomposition during use. Therefore, in such cases, using replacement products and recovering decomposed components may lead to delays in surgical procedures. All affected products are in good sterility. To date, we have not received any complaints worldwide related to these affected batches.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien llc
- Summary: Covidien LLC initiated a voluntary Class II recall of its Tissue Grasping Forceps for Endoscopic Surgery, as reported to the National Medical Products Administration (NMPA) on March 13, 2019, and published on March 21, 2019. The recall stems from a critical inconsistency identified during a review of manufacturing records: specific batches of the forceps, certified under National Medical Device Registration Certificate 20152222924, were not sterilized according to their approved method.
The primary issue was that products intended for V-ray sterilization were sometimes subjected to re-sterilization using ethylene oxide (EO) or additional V-ray exposure. While EO re-sterilization did not compromise product performance, it deviated from the stated labeling. Crucially, repeated V-ray sterilization increased the potential for product failure and component decomposition during use, which could lead to surgical delays. Despite these deviations, all recalled products maintained good sterility, and Covidien LLC confirmed no global complaints related to these affected batches.
The recall specifically targeted models 174317 and 173030 across various lot numbers, impacting markets in the United States, Canada, Japan, Europe, and Latin America. Notably, no affected products were sold in China, thus precluding the need for further corrective actions within that country. This recall highlights the importance of strict adherence to approved manufacturing and sterilization protocols in medical device production.

Company: https://www.globalkeysolutions.net/companies/covidien-llc/5111c5da-0a3d-4895-b59e-e49f0ad3547d/