Baxter Healthcare Corporation has initiated a voluntary recall for a wide range of cardiovascular surgery products because the marketing brochure distributed with them contains inaccurate information. This misinformation does not align with the products' official Instructions for Use (IFU) or Prescribing Information (PI). Products affected include surgical sealants like Coseal and Preveleak, FloSeal hemostatic matrices, vascular patches, vessel occluders, and intraluminal shunts. Because these errors could lead to the incorrect use of medical devices during surgery, consumers and healthcare providers should contact Baxter or their healthcare provider for updated guidance.
The use of inaccurate marketing material that contradicts official safety instructions can lead to the improper application or use of surgical sealants and patches during critical procedures. This poses a medium-level risk of surgical complications or device failure, although no specific patient injuries were reported in the recall data.
Information Correction
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.