(Health Times reporter Gao Ruirui) On December 30, the State Food and Drug Administration issued 9 recall announcements, and a large number of medical devices were recalled due to problems. The Health Times reporter combed and found that the recalled products include 2 secondary recalls and 7 tertiary recalls.
Products involved include Transend Guidewire from Boston Scientific, Multi-purpose solution for contact lens care solutions from Cooper Vision Manufacturing Co., Ltd., Multipurpose Solution for hydrogen peroxide contact lenses from CooperVision Manufacturing Ltd, Smith & Nephew, Jet-X external fixator instrument system produced by Inc., INBONE Total Ankle System produced by Ruiyi Medical Technology Co., Ltd., DePuy (Ireland), shoulder non-sterile surgical tool DePuy (Ireland) produced by Depeiyi (Ireland) Co., Ltd., hip prosthesis V40 produced by Stryker Holmedic Orthopedics, USA, Medtronic Inc. AFFINITY PIXIE Oxygenation SystemHeads, Intuitive Surgical, Inc.
Among them, Stryker (Beijing) Medical Device Co., Ltd. reported that due to the specific model and specific batch of products, there is a problem that the guide wire batch produced by Boston Scientific Corporation has been sterilized in a sterilization site not approved by the Japanese Ministry of Health, Labor and Welfare Guidewire (registration certificate number: National Machinery Injection 20173770330) voluntary recall. Medtronic (Shanghai) Management Co., Ltd. reported that Medtronic Inc. Medtronic voluntarily recalled the pediatric oxygenation system AFFINIT PIXIE Oxygenation System (registration certificate number: National Machinery Injection 20183102418), and the recall level is level 3.
In addition, it is worth noting that Cooper Optical Manufacturing Co., Ltd. announced two varieties of products recalled this time, both of which are tertiary recalls. However, none of the two products in the recall were sold in China, and the recall does not affect the domestic market.
Health Times reporter noted that since the beginning of this year, Medtronic has issued a number of recall notices, including the problem of potential security vulnerabilities in the MMT-503EU remote control due to the involvement of specific models and specific batches of products. Medtronic MiniMed, a manufacturer of Medtronic MiniMed, voluntarily recalled the insulin syringe pump Insulin Pump (registration certificate number: National Machinery Injection 20173141951), and the recall level is Level 1. With label/compliance issues involving specific models, specific batches of products, manufacturer Medtronic Inc. Medtronic voluntarily recalled the Implantable Defibrillation Electrode Lead (registration number: National Machinery Injection 20173217262), and the recall level is level 3.