China NMPA Product Recall - Solo Plus Hybrid Guidewire, a single-use sterile urinary guidewire

Heraeus Medical Components, LLC, in collaboration with Bard Medical Technology (Shanghai) Co., Ltd., has initiated a voluntary Class III recall for its Solo Plus Hybrid Guidewire, a single-use sterile urinary guidewire. This recall was officially published by the National Medical Products Administration (NMPA) on October 23, 2023. The primary reason for this action stems from a manufacturing deviation where a small quantity of pads, intended solely for sterilization processes and not for direct human contact, were inadvertently mixed into the finished product batches. This raises concerns regarding the guidewire's sterility and safety profile for medical use. The regulatory framework for this action is the NMPA, categorizing it as a Class III recall. Heraeus Medical Components, LLC is undertaking this voluntary recall as a required action to address and mitigate any potential risks associated with the affected products, ensuring compliance with medical device standards. Detailed information regarding the specific models, specifications, and batches involved is available in the 'Medical Device Recall Event Report Form'.