Abbott Medical Issues Class III Recall of AMPLATZER TorqVue Low Profile Delivery System Due to Mislabeled Product Model
Abbott Medical Optics
Ophthalmic Equipment Manufacturer
Original Title: Abbott Recalls Small Delivery Systems for Medical Devices Due to Mismatch Between Label Model and Product
(Beijing, March 19, CE.cn) – Reporter: Ma Xianzhen, Sun Chenwei. The National Medical Products Administration (NMPA) recently published a notice titled “Abbott Medical’s Voluntary Recall of Small Delivery Systems.” Abbott Medical Products (Shanghai) Co., Ltd. reported that due to mislabeling issues affecting specific models and batches, the manufacturer, Abbott Medical, has initiated a voluntary recall of its Small Delivery Systems (Registration Certificate No.: Guo Xie Zhu Jin 20173776760). The recall is classified as Class III.
The product subject to this recall is the AMPLATZER TorqVue Low Profile Delivery System, with registration certificate or filing voucher number Guo Xie Zhu Jin 20173776760. The manufacturer is Abbott Medical, and the agent is Abbott Medical Products (Shanghai) Co., Ltd. This product is intended for use by interventional cardiology specialists in the placement of AMPLATZER devices. The reason for the recall is that Abbott Medical received customerComplaint, the product batch 7406296 of the small conveyor system (model number 9-TVLP4F90/080) it produced had a discrepancy between the model number indicated on the English label and the actual product inside. Investigation confirmed that this was caused by an error in label application during the packaging process for this batch.
The countries and regions involved in this instance include Canada, Australia, the United Kingdom, Germany, and other EU countries and regions. The product models and specifications involved are 9-TVLP4F90/080. Since these products have not been imported into China, there is no involvement of sales quantities, batches, etc., within China.
As the affected batches of products were not imported into China, there are no distribution records in the Chinese market, and the company is not required to take any corrective actions.
According to inquiries made by reporters from China Economic Net, Abbott Medical Products (Shanghai) Co., Ltd. was established on June 24, 2003, with a registered capital of USD 7.846705 million, and is a wholly-owned subsidiary of ST. JUDE MEDICAL, LLC.
In the 2020 Global Top 100 Medical Device Companies, Abbott (Medical Device Segment) ranked 11th, with fiscal year sales of $12.239 billion.