Irvine Biomedical, Inc. Recalls Inquiry Steerable Diagnostic Catheters; Abbott Medical Serves as China Agent

Original Title: Irvine Biomedical Recalls Electrophysiology Diagnostic Catheters; Agent is Abbott Medical

Beijing, September 8 (CEC News) – On September 4, the National Medical Products Administration (NMPA) website published an announcement regarding the voluntary recall of Inquiry Steerable Diagnostic Catheters by Irvine Biomedical, Inc., a St. Jude Medical Company. Recently, Abbott Medical Devices (Shanghai) Co., Ltd. reported that due to mislabeling issues affecting specific models and batches—wherein the model numbers and batch information on the English labels did not match the actual products contained within—the manufacturer, Irvine Biomedical, Inc., a St. Jude Medical Company, has initiated a voluntary recall of its Inquiry Steerable Diagnostic Catheters (Registration Certificate No.: Guo Xie Zhu Jin 20153073669). The recall is classified as Class II.

The products involved in this recall are steerable electrophysiology diagnostic catheters. These products are intended for use in the diagnostic process of electrophysiology to record intracardiac electrograms and stimulate the heart. The registration certificate or filing voucher number is Guo Xie Zhu Jin 20153073669. The manufacturer is Irvine Biomedical, Inc., a St. Jude Medical Company, and the agent is Abbott Medical Products (Shanghai) Co., Ltd. The reason for the recall is that Irvine Biomedical received customerComplaint, for the batch (Lot No. 7397352) of its manufactured steerable electrophysiology diagnostic catheters (Model IBI-81104), the model and lot number indicated on the English label did not match the product contained within. Investigation confirmed that this discrepancy was caused by erroneous label application during the packaging process for this batch.

The affected batches of products were not imported into China, so no corrective actions are required in the Chinese market. The affected batches were sold only in the United States and Japan.

According to inquiries made by a reporter from China Economic Net, Abbott Medical Products (Shanghai) Co., Ltd. was established on June 24, 2003, with a registered capital of USD 7.8467 million. BRIAN B. YOOR serves as the legal representative and chairman of the board. The company is a wholly-owned subsidiary of ST. JUDE MEDICAL, LLC.

Founded in Chicago, USA, in 1888, Abbott Laboratories began its operations in China as early as the 1930s and has maintained a continuous presence since 1988. In addition to establishing its China headquarters in Shanghai, Abbott operates 23 offices, four manufacturing plants, and three research and development centers, employing more than 6,000 people. On May 13, 2020, Abbott ranked 158th on the Forbes Global 2000 list. In the 2019 global ranking of medical device companies, Abbott’s medical device segment ranked 11th in the United States, with revenues of US$11.4 billion.