Vascutek, Ltd. is recalling approximately 37,430 Gelsoft Plus and Gelweave gelatin-sealed vascular prostheses because they were incorrectly labeled with an extra month of shelf life. The expiration dates were calculated from the date of packaging rather than the date of manufacture (gel impregnation). This error means the devices may be used past their validated stability period.
Using a vascular graft beyond its intended shelf life may compromise the integrity or sterility of the gelatin seal used for vascular repair. While no injuries have been reported, using an expired medical device increases the risk of device failure or post-surgical complications.
Recall affects all devices where the item number ends in 'E-B'.
Recall affects all devices where the item number ends in 'E-B'.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.