OriGen Biomedical is recalling 3,613 units of Accessory Set Syringes, including the 6ml (REF: RF-T15) and 60ml (REF: 15-RF60-T) models. These syringes contain a plastic resin that is not compatible with the gamma sterilization process used during manufacturing, causing the syringe barrels to turn yellow. This material change has not been qualified for its intended medical use, which could impact the safety or performance of the device.
The use of a non-qualified resin and the subsequent reaction to sterilization can result in material degradation or the leaching of chemicals into the fluids being handled. This poses a potential risk to patients during medical procedures where these syringes are utilized for fluid transfer or measurement.
Manufacturer notification and guidance
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.