# China NMPA Product Recall - Central venous catheter kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-llc/d30ecfd4-029d-4574-859b-2bd437556b2d/
Source feed: China

> China NMPA product recall for Central venous catheter kit by Covidien llc published December 10, 2015. Recall level: . The National Medical Products Administration (NMPA) announced a voluntary global recall initiated by

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien LLC recalls central venous catheter kits
- Company Name: Covidien llc
- Publication Date: 2015-12-10
- Product Name: Central venous catheter kit
- Recall Reason: Medtronic is voluntarily recalling certain models and batch numbers of Covidien Palindrome™ catheters. The recall is due to a manufacturing defect that caused the device tip in the catheter packaging to bend. No customer complaints regarding this issue have been received. Use of products with this problem may increase the risk of reduced or no therapeutic effect and/or damage to the central vein. No patient injuries have been reported due to the catheter tip bending issue.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien llc
- Summary: The National Medical Products Administration (NMPA) announced a voluntary global recall initiated by Covidien LLC for specific central venous catheter kits. This recall, reported by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. on October 21, 2015, addresses a manufacturing process issue where the device's tip in the packaging was found to be bent. The affected products, identified by model 8888145042 and batch numbers 1503500094, 1431900098, and 1435800009, were intended for applications such as hemodialysis and fluid infusion. Although no customer complaints or patient injuries related to this particular issue have been reported, the bent tip could potentially lead to reduced or absent therapeutic effect or damage to the central vein. Importantly, none of the recalled products were imported into or sold within China. Consequently, no direct corrective actions are required for the Chinese market. However, under the NMPA's regulatory guidance, provincial and municipal food and drug administrations are advised to strengthen their supervision and management of similar medical devices.

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