Public Alert No. 016/2023 – Recall of Disposable Catheter Kits in China Due to Product Defect
May 18, 2023,
The National Agency for Food and Drugs Administration and Control (NAFDAC) is informing the public that the Chinese authorities have recalled two batches of disposable central venous Catheter kits manufactured by Shengzhen Yixinda Medical New Technology Co.,Ltd. The recall was due to the discovery of obstructed puncture needle in the affected batches during catheterization process.
Central venous catheter is a thin, flexible tube that is inserted into a vein, usually below the right collarbone, and guided (threaded) into a large vein above the right side of the heart called the superior vena cava. It is used to give intravenous fluids, blood transfusions, chemotherapy, and other drugs.
Several complications can occur that are directly related to the use of the dysfunctional central venous catheter. Potential complications from device dysfunction include: a fibrin sheath, a thrombosis, stenosis, an infection or a catheter fracture. A catheter fracture can lead to life-threatening conditions like sepsis, endocarditis, cardiac perforation, or arrhythmia development.
The details of the product are as follows;
Product Name: Central Venous Catheter Kit
Product Manufacturer: Shengzhen Yixinda Medical New Technology Co.,Ltd. China
Lot Number: 20221015, 20221008, 20221013
Although the product is not in NAFDAC database, importers, distributors, retailers, healthcare professionals and caregivers are advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the dysfunctional central venous catheter. All medical products and medical devices must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Members of the public are hereby advised to check if they have the affected batches in their possession. If so, you are advised to discontinue sale or use and submit stock to the nearest NAFDAC office.
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: email@example.com
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on firstname.lastname@example.org